<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03793556</url>
  </required_header>
  <id_info>
    <org_study_id>PSC-DS GERD AP 16</org_study_id>
    <nct_id>NCT03793556</nct_id>
  </id_info>
  <brief_title>Evaluation of GERDOFF Efficacy in Combination With Proton Pump Inhibitor</brief_title>
  <official_title>Evaluation of the Effects of GERDOFF in Combination With a 6-week Therapy Based on Proton Pump Inhibitors Versus Proton Pump Inhibitors Alone on GERD-high Symptoms in Patients With Primary Diagnosis of Gastroesophageal Reflux Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SOFAR S.p.A.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SOFAR S.p.A.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked&#xD;
      combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium&#xD;
      hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose,&#xD;
      versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal&#xD;
      GERD symptoms.&#xD;
&#xD;
      The investigators verified the reduction of symptoms frequency, using a Likert questionnaire,&#xD;
      and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion&#xD;
      of Responders and Non-Responder patients in these two groups after 6 weeks of treatment,&#xD;
      compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF®&#xD;
      + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any&#xD;
      documentable cause, are considered as minor disorders for which patients do not receive&#xD;
      adequate attention. These disorders may represent extra-esophageal manifestations of&#xD;
      gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been&#xD;
      proved as useful to improve patients' quality of life.&#xD;
&#xD;
      The aim of the present study was to evaluate, in first diagnosed patients presenting with&#xD;
      upper symptoms associated with GERD, the effect of a 6-week treatment with a combination&#xD;
      based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with&#xD;
      PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated&#xD;
      with the combination of the two products, the reduction in symptoms frequency by means of a&#xD;
      Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index&#xD;
      (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients&#xD;
      included in the two groups were then classified as responders or non-responders. Responder&#xD;
      patients were defined as those patients that, at the 6th week of treatment, reached a RSI&#xD;
      score decreased for at least 50% compared to baseline and an absolute value &lt; 13.&#xD;
&#xD;
      Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was&#xD;
      evaluated after a period of follow-up lasting 12 weeks, which could be entered only by&#xD;
      responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up&#xD;
      period were randomised to receive Gerdoff® or no treatment (control group). Safety data were&#xD;
      also evaluated in the group of patients that continued in the follow-up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients was randomized in an open-label treatment (in a ratio 1:1) and treated with the investigational medical device (IMD) + proton pump inhibitor (PPI) or PPI only for 6 weeks. At the end of treatment visit (V4) only patients who were classified as responders and belonging to the GERDOFF®+PPI group were included in the follow-up phase for 12 further weeks. During the follow-up, patients were randomized to an open-label treatment (in a 1:1 ratio) to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects. To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients that continued in the follow-up period received omeprazole as rescue medication, in a quantity adequate to cover the entire follow-up period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire</measure>
    <time_frame>In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)</time_frame>
    <description>After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed</measure>
    <time_frame>In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)</time_frame>
    <description>Total score of the Reflux Symptom Index questionnaire assessed in all time-points.&#xD;
The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4</measure>
    <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders V4</measure>
    <time_frame>At visit 4 after 6 weeks of treatment</time_frame>
    <description>A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Responders V6</measure>
    <time_frame>In the Visit 6 at the end of follow-up</time_frame>
    <description>Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.&#xD;
A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4</measure>
    <time_frame>At baseline and in the visit 4</time_frame>
    <description>The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);&#xD;
The Likert scale scores of single items are as following:&#xD;
Hoarseness or vocal problem 0 1 2 3 4&#xD;
Throat clearance 0 1 2 3 4&#xD;
Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4&#xD;
Difficulty in swallowing food, fluids or pills 0 1 2 3 4&#xD;
Cough after the meal or after lying 0 1 2 3 4&#xD;
Difficulty in breathing or episodes of choking 0 1 2 3 4&#xD;
Problematic or troublesome cough 0 1 2 3 4&#xD;
Sensation of something blocked or mass in the throat 0 1 2 3 4&#xD;
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.&#xD;
Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire</measure>
    <time_frame>At visit 4 after weeks of treatment</time_frame>
    <description>The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Rescue Medication (Omeprazole) During the Treatment</measure>
    <time_frame>From baseline to visit 4</time_frame>
    <description>In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Rescue Medication (Omeprazole) During the Follow-up</measure>
    <time_frame>In the Visit 6 after 12 weeks from baseline</time_frame>
    <description>During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Rescue Medication (Other Than Omeprazole) During Treatment</measure>
    <time_frame>From baseline to visit 4</time_frame>
    <description>During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients'Satisfaction</measure>
    <time_frame>At visit 4 after weeks of treatment</time_frame>
    <description>This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Gastro-oesophageal Reflux Disease</condition>
  <arm_group>
    <arm_group_label>GERDOFF® + omeprazole</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Omeprazole</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GERDOFF® + Omeprazole</intervention_name>
    <description>GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).</description>
    <arm_group_label>GERDOFF® + omeprazole</arm_group_label>
    <other_name>GERDOFF®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole</intervention_name>
    <description>Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
    <arm_group_label>Omeprazole</arm_group_label>
    <other_name>Omeprazen</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female subjects aged ≥ 18 years;&#xD;
&#xD;
          2. First diagnosis of GERD with upper symptoms, made on a clinical basis and confirmed by&#xD;
             an ENT and/or confirmed by a Gastroenterologist using a RSI questionnaire;&#xD;
&#xD;
          3. Presence of extra-oesophageal symptoms associated with GERD;&#xD;
&#xD;
          4. RSI score ≥ 20;&#xD;
&#xD;
          5. Patients not pre-treated with PPIs, even for problems different from GERD, and/or with&#xD;
             medical devices and/or similar products (e.g. antacid alginates etc..) in the last 4&#xD;
             weeks;&#xD;
&#xD;
          6. Cooperative patients, able to understand and adhere to the study procedures;&#xD;
&#xD;
          7. Patient able to freely give their written informed consent to study participation;&#xD;
&#xD;
          8. Patients that freely gave the consent to management of personal data related to the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known infective oesophagitis or oesophagitis due to acid or alkaline substances;&#xD;
&#xD;
          2. Acute or chronic rhinosinusitis;&#xD;
&#xD;
          3. Chronic bronchitis;&#xD;
&#xD;
          4. Known Zollinger-Ellison syndrome, hiatal hernia greater than 3 cm and Barrett&#xD;
             oesophagus;&#xD;
&#xD;
          5. Ongoing neoplasias;&#xD;
&#xD;
          6. Uncontrolled diabetes;&#xD;
&#xD;
          7. Patients with impaired liver function;&#xD;
&#xD;
          8. Patients with rare hereditary problems of galactose intolerance;&#xD;
&#xD;
          9. Patients that, based on Investigator's opinion, could not take part in the study due&#xD;
             to other diseases or concomitant therapies, such as the intake of atazanavir,&#xD;
             nelfinavir, clopidogrel, posaconazole and erlotinib (as recommended in the Summary of&#xD;
             Product Characteristics of Gerdoff®);&#xD;
&#xD;
         10. Patients with deficiency of Lapp lactase;&#xD;
&#xD;
         11. Patients with syndrome of glu-gal malabsorption;&#xD;
&#xD;
         12. Patients with hypersensitivity to omeprazole, substitute benzymidazolic or any of the&#xD;
             excipients;&#xD;
&#xD;
         13. Patients already in treatment with PPIs or similar products;&#xD;
&#xD;
         14. Chronic use of drugs that interfere with the salivary secretion (e.g. anti-histamines&#xD;
             or inhaled steroids);&#xD;
&#xD;
         15. Abuse of drug or alcohol;&#xD;
&#xD;
         16. Inability of the subject to adequately express his/her disturbances;&#xD;
&#xD;
         17. Patients with planned or ascertained pregnancy or that did not adopt an accepted&#xD;
             contraceptive method;&#xD;
&#xD;
         18. Lactating patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandro Repici, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Clinico Humanitas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>dr Alessandro Repici</name>
      <address>
        <city>Rozzano</city>
        <state>MI</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <results_first_submitted>December 9, 2019</results_first_submitted>
  <results_first_submitted_qc>March 16, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 18, 2020</results_first_posted>
  <last_update_submitted>March 18, 2020</last_update_submitted>
  <last_update_submitted_qc>March 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Omeprazole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03793556/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A first specialist visit was performed by an ENT as per clinical practice based on patient's symptoms.&#xD;
Patients sent by the ENT should not have been pre-treated with PPIs and/or medical devices and/or similar products. The diagnosis was confirmed by the Gastroenterologist Investigator who recruited patients.</recruitment_details>
      <pre_assignment_details>In this phase of the study, 72 patients were enrolled. One patient withdrew the informed consent and was excluded from the study before randomization.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>GERDOFF® + Omeprazole</title>
          <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
        </group>
        <group group_id="P2">
          <title>Omeprazole</title>
          <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>GERDOFF® + Omeprazole</title>
          <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
        </group>
        <group group_id="B2">
          <title>Omeprazole</title>
          <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="35"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="71"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.0" lower_limit="20" upper_limit="86"/>
                    <measurement group_id="B2" value="45.0" lower_limit="20" upper_limit="76"/>
                    <measurement group_id="B3" value="46.0" lower_limit="20" upper_limit="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients with simultaneous symptoms</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>1 symptom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>7 symptoms</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hoarseness or vocal problem</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Throat clearance</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Excess of mucus in the throat or retrosternal fall of secretions</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Difficulty in swallowing food, fluids or pills</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cough after the meal or after lying</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Difficulty in breathing or episodes of choking</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="31"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Problematic or troublesome cough</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sensation of something blocked or mass in the throat</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>yes</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>no</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <population>Some data are missing in both arms</population>
          <units>kg</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.0" lower_limit="45.0" upper_limit="98.6"/>
                    <measurement group_id="B2" value="62.0" lower_limit="43.0" upper_limit="95.0"/>
                    <measurement group_id="B3" value="62.5" lower_limit="43" upper_limit="98.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <population>Some data are missing in both arms</population>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="29"/>
                    <count group_id="B2" value="31"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.6" lower_limit="17.6" upper_limit="35.2"/>
                    <measurement group_id="B2" value="22.7" lower_limit="16.8" upper_limit="38.6"/>
                    <measurement group_id="B3" value="22.7" lower_limit="16.8" upper_limit="38.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of symptoms</title>
          <units>Symptom</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="35"/>
                    <count group_id="B2" value="36"/>
                    <count group_id="B3" value="71"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="B2" value="4" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="B3" value="4" lower_limit="1" upper_limit="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire</title>
        <description>After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
        <time_frame>In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)</time_frame>
        <population>Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire</title>
          <description>After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
          <population>Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.</population>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-16.2" spread="7.45"/>
                    <measurement group_id="O2" value="-13.7" spread="10.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.276</p_value>
            <method>Unpaired t test</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>-2.5</param_value>
            <dispersion_type>Standard Deviation</dispersion_type>
            <dispersion_value>9.27</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.03</ci_lower_limit>
            <ci_upper_limit>2.04</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed</title>
        <description>Total score of the Reflux Symptom Index questionnaire assessed in all time-points.&#xD;
The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
        <time_frame>In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)</time_frame>
        <population>Some data are missing; therefore, the number of participants in one or more rows differs from overall number analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed</title>
          <description>Total score of the Reflux Symptom Index questionnaire assessed in all time-points.&#xD;
The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).</description>
          <population>Some data are missing; therefore, the number of participants in one or more rows differs from overall number analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="35"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.2" spread="5.18"/>
                    <measurement group_id="O2" value="26.0" spread="4.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.3" spread="7.86"/>
                    <measurement group_id="O2" value="19.6" spread="7.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                    <count group_id="O2" value="35"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9" spread="7.77"/>
                    <measurement group_id="O2" value="15.3" spread="8.08"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="36"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9" spread="6.04"/>
                    <measurement group_id="O2" value="12.3" spread="8.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0157</p_value>
            <method>ANOVA</method>
            <method_desc>The ANOVA model examined the entire curve profile.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="1.35"/>
                    <measurement group_id="O2" value="2.8" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.33"/>
                    <measurement group_id="O2" value="1.6" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.22"/>
                    <measurement group_id="O2" value="3.6" spread="1.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.39"/>
                    <measurement group_id="O2" value="1.8" spread="1.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.76"/>
                    <measurement group_id="O2" value="2.8" spread="1.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.31"/>
                    <measurement group_id="O2" value="1.9" spread="1.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.66"/>
                    <measurement group_id="O2" value="1.9" spread="1.84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.71"/>
                    <measurement group_id="O2" value="0.6" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.76"/>
                    <measurement group_id="O2" value="3.3" spread="1.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.01"/>
                    <measurement group_id="O2" value="1.7" spread="1.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.60"/>
                    <measurement group_id="O2" value="1.9" spread="1.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5" spread="1.15"/>
                    <measurement group_id="O2" value="0.6" spread="0.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.65"/>
                    <measurement group_id="O2" value="3.7" spread="1.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.17"/>
                    <measurement group_id="O2" value="1.5" spread="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.52"/>
                    <measurement group_id="O2" value="2.6" spread="1.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.08"/>
                    <measurement group_id="O2" value="1.6" spread="1.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
        <time_frame>At baseline and in the visit 4, after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment will last 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.56"/>
                    <measurement group_id="O2" value="3.5" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8" spread="1.08"/>
                    <measurement group_id="O2" value="3.5" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders V4</title>
        <description>A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
        <time_frame>At visit 4 after 6 weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders V4</title>
          <description>A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0496</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Responders V6</title>
        <description>Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.&#xD;
A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
        <time_frame>In the Visit 6 at the end of follow-up</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>No Treated</title>
            <description>Responder patients of Group Gerdoff® + omeprazole were randomly assigned to the control group.&#xD;
All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Responders V6</title>
          <description>Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.&#xD;
A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value &lt; 13 on the RSI questionnaire.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4</title>
        <description>The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);&#xD;
The Likert scale scores of single items are as following:&#xD;
Hoarseness or vocal problem 0 1 2 3 4&#xD;
Throat clearance 0 1 2 3 4&#xD;
Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4&#xD;
Difficulty in swallowing food, fluids or pills 0 1 2 3 4&#xD;
Cough after the meal or after lying 0 1 2 3 4&#xD;
Difficulty in breathing or episodes of choking 0 1 2 3 4&#xD;
Problematic or troublesome cough 0 1 2 3 4&#xD;
Sensation of something blocked or mass in the throat 0 1 2 3 4&#xD;
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.&#xD;
Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.</description>
        <time_frame>At baseline and in the visit 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4</title>
          <description>The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);&#xD;
The Likert scale scores of single items are as following:&#xD;
Hoarseness or vocal problem 0 1 2 3 4&#xD;
Throat clearance 0 1 2 3 4&#xD;
Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4&#xD;
Difficulty in swallowing food, fluids or pills 0 1 2 3 4&#xD;
Cough after the meal or after lying 0 1 2 3 4&#xD;
Difficulty in breathing or episodes of choking 0 1 2 3 4&#xD;
Problematic or troublesome cough 0 1 2 3 4&#xD;
Sensation of something blocked or mass in the throat 0 1 2 3 4&#xD;
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.&#xD;
Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.</description>
          <units>Score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.0" spread="4.301"/>
                    <measurement group_id="O2" value="21" spread="4.557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Visit 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.4" spread="5.667"/>
                    <measurement group_id="O2" value="11.6" spread="8.083"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>0.0065</p_value>
            <method>ANOVA</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire</title>
        <description>The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).</description>
        <time_frame>At visit 4 after weeks of treatment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire</title>
          <description>The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 symptom</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 symptoms</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Rescue Medication (Omeprazole) During the Treatment</title>
        <description>In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.</description>
        <time_frame>From baseline to visit 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Rescue Medication (Omeprazole) During the Treatment</title>
          <description>In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="35"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Rescue Medication (Omeprazole) During the Follow-up</title>
        <description>During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
        <time_frame>In the Visit 6 after 12 weeks from baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>No Treated</title>
            <description>Responder patients of Group Gerdoff® + omeprazole were randomly assigned to the control group.&#xD;
All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Rescue Medication (Omeprazole) During the Follow-up</title>
          <description>During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Rescue Medication (Other Than Omeprazole) During Treatment</title>
        <description>During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
        <time_frame>From baseline to visit 4</time_frame>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Rescue Medication (Other Than Omeprazole) During Treatment</title>
          <description>During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patients'Satisfaction</title>
        <description>This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).</description>
        <time_frame>At visit 4 after weeks of treatment</time_frame>
        <population>Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>GERDOFF® + Omeprazole</title>
            <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
          </group>
          <group group_id="O2">
            <title>Omeprazole</title>
            <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
          </group>
        </group_list>
        <measure>
          <title>Patients'Satisfaction</title>
          <description>This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).</description>
          <population>Four patients in the GERFOFF + omeprazole group did not complete the Reflux Symptom Index questionnaire and could not be included in the analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Discrete</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Good</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Excellent</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the 6 weeks of treatment in non-responders in the group GERDOFF+PPI and in patients randomized in PPI group; during the 6 weeks of treatment and 12-week follow-up in responder patients randomized in the group GERDOFF + PPI</time_frame>
      <group_list>
        <group group_id="E1">
          <title>GERDOFF® + Omeprazole</title>
          <description>GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
GERDOFF®: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg</description>
        </group>
        <group group_id="E2">
          <title>Omeprazole</title>
          <description>Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).&#xD;
Omeprazole: Omeprazole, 2 capsules 20 mg, once a day before breakfast</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA (20.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="35"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Dysentery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Flu-like symptoms</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertransaminasaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Red blood cell sedimentation rate increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>C-reactive protein increased subjects affected / exposed</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>neck pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Clonus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Francesca Baldan</name_or_title>
      <organization>Sofar Spa</organization>
      <phone>0039 02 909362 ext 1</phone>
      <email>francesca.baldan@sofarfarm.it</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03793556
org study id: PSC-DS GERD AP 16
nct id: NCT03793556
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study was to evaluate the effect of a 6-weeks treatment of a CE-marked
      combination oral formulation of hyaluronic acid with chondroitin sulphate and aluminium
      hydroxide (GERDOFF®), in addition to proton pump inhibitors (PPI) at the standard dose,
      versus PPI only, in patients with first diagnosed clinical presentation of extra-esophageal
      GERD symptoms.

      The investigators verified the reduction of symptoms frequency, using a Likert questionnaire,
      and severity, using the Reflux Symptom Index (RSI) questionnaire, to evaluate the proportion
      of Responders and Non-Responder patients in these two groups after 6 weeks of treatment,
      compared to baseline. Moreover investigators evaluated the persistence of effects of GERDOFF®
      + PPI treatment on extraesophageal symptoms, after a 12-weeks follow up, only in responder
      patients.
Cough, hoarseness, prolonged voice lowering, and vocal timbre modification, without any
      documentable cause, are considered as minor disorders for which patients do not receive
      adequate attention. These disorders may represent extra-esophageal manifestations of
      gastro-oesophagea reflux. Accurate diagnosis and gastro-oesophageal reflux therapy have been
      proved as useful to improve patients' quality of life.

      The aim of the present study was to evaluate, in first diagnosed patients presenting with
      upper symptoms associated with GERD, the effect of a 6-week treatment with a combination
      based on CS, HA and aluminium hydroxide (Gerdoff®), co-administered with a treatment with
      PPIs, compared to treatment with PPIs as monotherapy, i.e. to verify, in patients treated
      with the combination of the two products, the reduction in symptoms frequency by means of a
      Likert questionnaire and the severity of upper symptoms by means of the Reflux Symptom Index
      (RSI) questionnaire, and to collect safety data. After 6 weeks of treatment, patients
      included in the two groups were then classified as responders or non-responders. Responder
      patients were defined as those patients that, at the 6th week of treatment, reached a RSI
      score decreased for at least 50% compared to baseline and an absolute value < 13.

      Furthermore, the maintenance of the effect of treatment on the extra-oesophageal symptoms was
      evaluated after a period of follow-up lasting 12 weeks, which could be entered only by
      responder patients randomised in the Gerdoff®-PPI arm. Patients included in the follow-up
      period were randomised to receive Gerdoff® or no treatment (control group). Safety data were
      also evaluated in the group of patients that continued in the follow-up period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients was randomized in an open-label treatment (in a ratio 1:1) and treated with the investigational medical device (IMD) + proton pump inhibitor (PPI) or PPI only for 6 weeks. At the end of treatment visit (V4) only patients who were classified as responders and belonging to the GERDOFF®+PPI group were included in the follow-up phase for 12 further weeks. During the follow-up, patients were randomized to an open-label treatment (in a 1:1 ratio) to GERDOFF® group or control group that will not receive any treatment for 12 weeks in order to evaluate the maintenance of treatment effects. To safeguard the health and well-being of patients, and to keep under control the possible upper symptoms of GERD that could appear, all patients that continued in the follow-up period received omeprazole as rescue medication, in a quantity adequate to cover the entire follow-up period.
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline to Visit V4 of the Total Score of RSI Questionnaire
time frame: In the first visit (baseline) and in the visit 4 (after 6 weeks of treatment)
description: After 6 weeks of treatment, the changes from baseline in the score of Reflux Symptom Index questionnaire were evaluated to verify the effects of treatments on high symptoms. The RSI questionnaire examines 9 items that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).
measure: Total Score of Reflux Symptom Index Questionnaire in All Time-points Assessed
time frame: In baseline Visit, Visit 2 (after 1 week), Visit 3 (after 3 weeks) and Visit 4 (after 6 weeks of treatment)
description: Total score of the Reflux Symptom Index questionnaire assessed in all time-points.
The RSI questionnaire examines 9 items, that are scored from 0 to 5, with a higher score that indicates a higher severity of the symptom (range of total score: 0-45).
measure: Score of Hoarseness or Vocal Problem of the RSI Questionnaire Measured at the Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including hoarseness or vocal problem that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Throat of the RSI Questionnarie Measured at the Baseline and in the Visit 4 of the RSI Questionnaire Score of Throat Clearance
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Excess of Mucus in the Throat or Retrosternal Fall of Secretions of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including excess of mucus in the throat or retrosternal fall of secretions that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Difficulty in Swallowing Food, Fluids or Pills of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including difficulty in swallowing food, fluids or pills that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4 After the Meal or After Lying
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Difficulty in Breathing or Episodes of Choking of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including difficulty in breathing or episodes of choking that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Problematic or Troublesome Cough of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including problematic or troublesome cough that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Sensation of Something Blocked or Mass in the Throat of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including sensation of something blocked or mass in the throat that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Score of Stomach Burning, Thoracic Pain, Poor Digestion of Gastric Acid That Moves Upright of the RSI Questionnaire Measured at Baseline and in the Visit 4
time frame: At baseline and in the visit 4, after 6 weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, including stomach burning, thoracic pain, poor digestion of gastric acid that moves upright that is score from 0 to 5, with a higher score that indicates a higher severity of the symptom.
measure: Number of Responders V4
time frame: At visit 4 after 6 weeks of treatment
description: A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire.
measure: Number of Responders V6
time frame: In the Visit 6 at the end of follow-up
description: Responder patients of Group Gerdoff® + omeprazole were randomly assigned to receive a treatment with Gerdoff®-one tablet three times daily- All patients received a packaging of omeprazole, to be taken only if necessary, at constant dose and according to the indications of the Investigator. The scheduled duration of the follow-up period was 12 weeks.
A responder was defined as a patient who at the 6th week of treatment showed a reduction of at least 50% vs. the baseline and an absolute value < 13 on the RSI questionnaire.
measure: Score of Upper Symptoms Using the Likert Scale at Baseline and in the Visit V4
time frame: At baseline and in the visit 4
description: The Likert scale examines 9 symptoms, to be scored from 0 to 4, with a higher score indication a higher frequency of the symptom (i.e. 0=never, 1=occasionally, 2=sometimes, 3= often, 4=Always);
The Likert scale scores of single items are as following:
Hoarseness or vocal problem 0 1 2 3 4
Throat clearance 0 1 2 3 4
Excess of mucus in the throat or retrosternal fall of secretions 0 1 2 3 4
Difficulty in swallowing food, fluids or pills 0 1 2 3 4
Cough after the meal or after lying 0 1 2 3 4
Difficulty in breathing or episodes of choking 0 1 2 3 4
Problematic or troublesome cough 0 1 2 3 4
Sensation of something blocked or mass in the throat 0 1 2 3 4
Stomach burning, thoracic pain, poor digestion of gastric acid that moves upright 0 1 2 3 4.
Subscales are summarized to compute a total score (total score ranges from 0-36). The mean values of Likert scale total score are reported.
measure: Presence of Upper Symptoms at Visit 4, Using the RSI Questionnaire
time frame: At visit 4 after weeks of treatment
description: The Reflux Symptom Index questionnaire examines 9 items, to be scored from 0 to 5, with a higher score indication a higher severity of the symptom (range of total score: 0-45).
measure: Use of Rescue Medication (Omeprazole) During the Treatment
time frame: From baseline to visit 4
description: In the first 6 weeks of treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug and the comparison between groups was performed using the Fisher's exact test.
measure: Use of Rescue Medication (Omeprazole) During the Follow-up
time frame: In the Visit 6 after 12 weeks from baseline
description: During the follow-up, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.
measure: Use of Rescue Medication (Other Than Omeprazole) During Treatment
time frame: From baseline to visit 4
description: During treatment, the intake in each treatment group of the rescue medication, allowed or not allowed, was calculated as the frequency of intake of the specific drug.
measure: Patients'Satisfaction
time frame: At visit 4 after weeks of treatment
description: This evaluation was expressed with a semi-quantitative ordinal scale: 0 = low, 1 = discrete, 2 = good, 3 = excellent).
arm group label: GERDOFF® + omeprazole
arm group type: Experimental
description: GERDOFF® (tablets) was orally administered 3 times per day after meals; omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
arm group label: Omeprazole
arm group type: Active Comparator
description: Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
intervention type: Device
intervention name: GERDOFF® + Omeprazole
description: GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
arm group label: GERDOFF® + omeprazole
other name: GERDOFF®
intervention type: Drug
intervention name: Omeprazole
description: Omeprazole, 2 capsules 20 mg, once a day before breakfast
arm group label: Omeprazole
other name: Omeprazen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Repici, MD
role: Principal Investigator
affiliation: Istituto Clinico Humanitas
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Gastroesophageal Reflux
mesh term: Omeprazole
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 