<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/NCT03238534</url>
  </required_header>
  <id_info>
    <org_study_id>ABO-NB-15</org_study_id>
    <nct_id>NCT03238534</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Evaluation of Neobianacid® in GERD and EPS</brief_title>
  <official_title>Relief of Heartburn and Epigastric Pain Comparing Neobianacid® With Omeprazole: a Randomized, Double Blind, Double Dummy, Reference Product Controlled, Parallel Group, Non-inferiority Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aboca Spa Societa' Agricola</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Doppel Farmaceutici</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>BMR Genomics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Aboca Spa Societa' Agricola</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>
      Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or&#xD;
      epigastric pain&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Comparison of heartburn or epigastric pain severity following administration of Neobianacid®&#xD;
      (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also&#xD;
      administered in both treatment arms. Then, a following phase (day 28-55) will follows in&#xD;
      which Neobianacid® will be administered (on demand) to both treatment arms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">September 3, 2021</completion_date>
  <primary_completion_date type="Actual">September 3, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double Blind (patient+investigator)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Heartburn or epigastric pain severity through treatment (Day-1 to Day13)</measure>
    <time_frame>Day-1 to Day13</time_frame>
    <description>Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from &quot;no symptoms&quot; to &quot;overwhelming symptoms&quot;); from Baseline to Day 13, between groups. Baseline is defined as Day -1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heartburn or epigastric pain severity through treatment (Day-1 to Day7)</measure>
    <time_frame>Day-1 to Day7</time_frame>
    <description>Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from &quot;no symptoms&quot; to &quot;overwhelming symptoms&quot;) from Baseline to Day 1, Day 3 and Day 7, between groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heartburn or epigastric pain severity through treatment (Day14 to Day27)</measure>
    <time_frame>Day14 to Day27</time_frame>
    <description>Assessment of heartburn or epigastric pain severity by means of a 100mm VAS scale (from &quot;no symptoms&quot; to &quot;overwhelming symptoms&quot;); from Day 14 to Day 27 between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of of rescue medication use</measure>
    <time_frame>Day-1 to Day55</time_frame>
    <description>Assessment of use (starting date and quantity) of rescue medication (antacid); from Baseline to Day 13, from Day 14 to Day 27 and from Day 28 to Day 55, between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27</measure>
    <time_frame>Day14 to Day27</time_frame>
    <description>Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; from Day 14 to Day 27, between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55</measure>
    <time_frame>Day28 to Day55</time_frame>
    <description>Assessment of number of tablets of Neobianacid® on demand; from Day 28 to Day 55, between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in symptomatology</measure>
    <time_frame>Day-1 to Day56</time_frame>
    <description>Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire - GSRS; Day 14, Day 28 and Day 56 versus Baseline, between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in quality of life</measure>
    <time_frame>Day-1 to Day56</time_frame>
    <description>Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; Day 14, Day 28 and Day 56 versus Baseline, between groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of treatment</measure>
    <time_frame>Day-1 to Day56</time_frame>
    <description>Evaluation of treatment by means of Overall Treatment Evaluation - OTE; Day 14, 28 and 56, between groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>intestinal microbiota characterization</measure>
    <time_frame>Day-1 and Day28</time_frame>
    <description>Characterization of the whole intestinal microbiota carried out by means of the analysis of faecal samples; Baseline and Day 28.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">275</enrollment>
  <condition>GERD</condition>
  <condition>EPS</condition>
  <arm_group>
    <arm_group_label>Omeprazole 20mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will be provided with enough amount of 20 mg omeprazole [30' before meal] and Neobianacid® placebo [30' after meal] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication.&#xD;
Treatment regimen:&#xD;
Day 0-13 Breakfast: Omeprazole + Neobianacid® placebo; Lunch: Neobianacid® placebo; Midafternoon: Neobianacid® placebo; Dinner: Neobianacid® placebo; Before going to bed: Neobianacid® placebo.&#xD;
Day14-27 Breakfast: Omeprazole+ Neobianacid® placebo on demand Lunch: Neobianacid® placebo on demand Dinner: Neobianacid® placebo on demand Any other time: Neobianacid® placebo on demand, if needed&#xD;
Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neobianacid®</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with enough amount of Omeprazole placebo [30' before meal] and Neobianacid® [30' after meal] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication.&#xD;
Treatment regimen:&#xD;
Day 0-13 Breakfast: Omeprazole placebo + Neobianacid® Lunch: Neobianacid® Midafternoon: Neobianacid® Dinner: Neobianacid® Before going to bed: Neobianacid®&#xD;
Day14-27 Breakfast: Omeprazole placebo + Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed&#xD;
Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neobianacid®</intervention_name>
    <description>Oral administrations of Neobianacid® (30' after meals and on demand)</description>
    <arm_group_label>Neobianacid®</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Omeprazole 20mg</intervention_name>
    <description>Daily administration Omeprazole 20mg (per os, 30' before breakfast).</description>
    <arm_group_label>Omeprazole 20mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neobianacid® placebo</intervention_name>
    <description>Oral administrations of Neobianacid® placebo (30' after meals and on demand)</description>
    <arm_group_label>Omeprazole 20mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Omeprazole placebo</intervention_name>
    <description>Daily administration Omeprazole placebo (per os, 30' before breakfast).</description>
    <arm_group_label>Neobianacid®</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients 18 - 70 years old (inclusive).&#xD;
&#xD;
          2. Patients presenting one or both the 2 following conditions:&#xD;
&#xD;
               -  Patients presenting heartburn who have been already diagnosed with uncomplicated&#xD;
                  gastroesophageal reflux disease (GERD) or whose symptoms are consistent with a&#xD;
                  clinical diagnosis of uncomplicated GERD.&#xD;
&#xD;
               -  Patients who have been already diagnosed with uncomplicated Epigastric Pain&#xD;
                  Syndrome (EPS) or whose symptoms are consistent with a clinical diagnosis of&#xD;
                  uncomplicated EPS according to Rome III criteria.&#xD;
&#xD;
          3. A gastroscopy is to be performed if not already performed during the previous 3 years&#xD;
             and the symptomatology is unchanged.&#xD;
&#xD;
          4. Patients having a VAS score ≥ 30mm and ≤ 70mm (VAS related to heartburn/ epigastric&#xD;
             pain) for at least 6 out of 14 days preceding the screening visit.&#xD;
&#xD;
          5. Postmenopausal women i.e. women who have not experienced a menstrual bleed for a&#xD;
             minimum of 12 months or women who have undergone surgical sterilization (tubal closure&#xD;
             or ovaries removal). Otherwise, necessity for women of childbearing potential to&#xD;
             follow a reliable contraceptive treatment.&#xD;
&#xD;
          6. Ability of the patients (in the Investigator's opinion) to comprehend the full nature&#xD;
             and purpose of the study including possible risks and side effects.&#xD;
&#xD;
          7. Patients who agree not to alter their diet in any way for the duration of the trial&#xD;
             and to maintain it at steady state.&#xD;
&#xD;
          8. Patients who agree not to make any major lifestyle changes during the trial.&#xD;
&#xD;
          9. Consent to the study and willing to comply with all its procedures.&#xD;
&#xD;
         10. Chronic therapies (if not related to the gastroenterological pathologies object of the&#xD;
             study, according to the opinion of Investigator) are allowed, if the regimen is&#xD;
             maintained stable during the whole study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with heartburn/epigastric pain who have not previously responded to antacid&#xD;
             or PPI.&#xD;
&#xD;
          2. Patients having a VAS score &gt; 70mm (VAS related to heartburn/ epigastric pain) for at&#xD;
             least 6 out of 14 days preceding the screening visit.&#xD;
&#xD;
          3. Patient presenting one of the following condition:&#xD;
&#xD;
               1. anemia;&#xD;
&#xD;
               2. chronic gastrointestinal bleeding;&#xD;
&#xD;
               3. antibiotic use, including antifungal and antimalarial medication within 2 months&#xD;
                  preceding the start of the study;&#xD;
&#xD;
               4. progressive unintentional weight loss;&#xD;
&#xD;
               5. persistent or recurrent vomiting;&#xD;
&#xD;
               6. epigastric mass;&#xD;
&#xD;
               7. acute episode with dyspnea, diaphoresis, or tachycardia;&#xD;
&#xD;
               8. anorexia;&#xD;
&#xD;
               9. nausea or vomiting;&#xD;
&#xD;
              10. dysphagia or odynophagia.&#xD;
&#xD;
          4. Patients under triple therapy or eradication therapy against Helicobacter pylori.&#xD;
&#xD;
          5. Patients using any drugs that could affect symptoms, such as NSAIDS, antacids, anti-&#xD;
             secretory agents including proton pump inhibitors (other than the study products) and&#xD;
             histamine H2-receptor antagonists or prokinetic or antiulcer agents, gastric mucosal&#xD;
             protectants, anticholinergics and/or cholinergic agents. Moreover, the patients will&#xD;
             be asked to avoid any drugs of the above mentioned since the beginning of the study&#xD;
             (since pre-screening visit) until the end of the study.&#xD;
&#xD;
          6. Patients with the presence of the following conditions: erosive GERD, Barrett's&#xD;
             oesophagus or oesophageal stricture, active or healing gastroduodenal ulcer (except&#xD;
             scars) or any other GI disease, which is not mentioned in the inclusion criteria;&#xD;
             history of gastric, duodenal or esophageal surgery; malignant disease of any kind;&#xD;
             gallstone. Any chronic disease that may affect the gastrointestinal upper tract.&#xD;
&#xD;
          7. Patients with clinically significant liver disease (AST/SGOT, ALT/SGPT &gt;2 upper limits&#xD;
             of normal).&#xD;
&#xD;
          8. Patients with clinically significant renal disease (serum creatinine &gt;1.5 mg/dl).&#xD;
&#xD;
          9. Patient having any other conditions or disease that the Investigator will consider&#xD;
             non-appropriate to the study (any severe disease of another major body system other&#xD;
             than GI tract).&#xD;
&#xD;
         10. Patients with porphyria, hypophosphatemia, cachexia.&#xD;
&#xD;
         11. Pregnant or nursing women or women planning to become pregnant during the study.&#xD;
&#xD;
         12. Patients with a history of alcohol or drug abuse.&#xD;
&#xD;
         13. Known hypersensitivity or intolerance to any components of the study products or&#xD;
             rescue medication.&#xD;
&#xD;
         14. Subjects presenting contraindications to the study products or rescue medication,&#xD;
             according to concerning Summaries of Product Characteristics (SPC), e.g. for&#xD;
             omeprazole, patients suffering from rare hereditary problems of fructose intolerance,&#xD;
             Glucose Galactose Malabsorption (GGM) or sucrase-isomaltase deficiency.&#xD;
&#xD;
         15. Patients being treated with any drug whose pharmacokinetics can interfere with the&#xD;
             intake of omeprazole or magaldrate (e.g., for omeprazole, the active substances known&#xD;
             as CYP2C19 or CYP3A4 inhibitors, as clarithromycin and voriconazole, or inductors, as&#xD;
             rifampicin and St. John's wort, Hypericum, or both) or with any drug with which&#xD;
             omeprazole, neobianacid or magaldrate are able to interact.&#xD;
&#xD;
         16. Patient participating to any investigational drug trial within 4 weeks before&#xD;
             screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliera Santa Maria Goretti</name>
      <address>
        <city>Latina</city>
        <state>Rome</state>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Civile San Salvatore</name>
      <address>
        <city>L'Aquila</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico San Matteo Pavia Fondazione IRCCS</name>
      <address>
        <city>Pavia</city>
        <zip>27100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Perugia</name>
      <address>
        <city>Perugia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Sant'Andrea</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Giovanni Addolorata</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sandro Pertini</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale Sant'Eugenio</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Umberto I</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario A. Gemelli</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Policlinico Universitario Campus Biomedico di Roma</name>
      <address>
        <city>Rome</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'Aragona</name>
      <address>
        <city>Salerno</city>
        <zip>84131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03238534
org study id: ABO-NB-15
nct id: NCT03238534
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of Neobianacid® clinical efficacy to omeprazole in relief of heartburn or
      epigastric pain
Comparison of heartburn or epigastric pain severity following administration of Neobianacid®
      (Group B) or omeprazole (Group A) from day 0 to day 27. An ad-hoc placebo will be also
      administered in both treatment arms. Then, a following phase (day 28-55) will follows in
      which Neobianacid® will be administered (on demand) to both treatment arms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Double Blind (patient+investigator)
measure: Heartburn or epigastric pain severity through treatment (Day-1 to Day13)
time frame: Day-1 to Day13
description: Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms"); from Baseline to Day 13, between groups. Baseline is defined as Day -1
measure: Heartburn or epigastric pain severity through treatment (Day-1 to Day7)
time frame: Day-1 to Day7
description: Comparison of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms") from Baseline to Day 1, Day 3 and Day 7, between groups
measure: Heartburn or epigastric pain severity through treatment (Day14 to Day27)
time frame: Day14 to Day27
description: Assessment of heartburn or epigastric pain severity by means of a 100mm VAS scale (from "no symptoms" to "overwhelming symptoms"); from Day 14 to Day 27 between groups.
measure: Assessment of of rescue medication use
time frame: Day-1 to Day55
description: Assessment of use (starting date and quantity) of rescue medication (antacid); from Baseline to Day 13, from Day 14 to Day 27 and from Day 28 to Day 55, between groups.
measure: Tablets of Neobianacid® Vs. Neobianacid® placebo Day14 to Day27
time frame: Day14 to Day27
description: Assessment of number of tablets of Neobianacid® on demand in comparison to Neobianacid® placebo on demand; from Day 14 to Day 27, between groups.
measure: Tablets of Neobianacid® Vs. Neobianacid® placebo Day28 to Day55
time frame: Day28 to Day55
description: Assessment of number of tablets of Neobianacid® on demand; from Day 28 to Day 55, between groups.
measure: Improvement in symptomatology
time frame: Day-1 to Day56
description: Improvement in symptomatology, by means of Gastrointestinal Symptom Rating Scale Questionnaire - GSRS; Day 14, Day 28 and Day 56 versus Baseline, between groups.
measure: Improvement in quality of life
time frame: Day-1 to Day56
description: Improvement in quality of life, by means of Gastrointestinal Quality of Life Index - GIQLI questionnaire; Day 14, Day 28 and Day 56 versus Baseline, between groups.
measure: Evaluation of treatment
time frame: Day-1 to Day56
description: Evaluation of treatment by means of Overall Treatment Evaluation - OTE; Day 14, 28 and 56, between groups.
measure: intestinal microbiota characterization
time frame: Day-1 and Day28
description: Characterization of the whole intestinal microbiota carried out by means of the analysis of faecal samples; Baseline and Day 28.
arm group label: Omeprazole 20mg
arm group type: Active Comparator
description: Patients will be provided with enough amount of 20 mg omeprazole [30' before meal] and Neobianacid® placebo [30' after meal] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication.
Treatment regimen:
Day 0-13 Breakfast: Omeprazole + Neobianacid® placebo; Lunch: Neobianacid® placebo; Midafternoon: Neobianacid® placebo; Dinner: Neobianacid® placebo; Before going to bed: Neobianacid® placebo.
Day14-27 Breakfast: Omeprazole+ Neobianacid® placebo on demand Lunch: Neobianacid® placebo on demand Dinner: Neobianacid® placebo on demand Any other time: Neobianacid® placebo on demand, if needed
Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed
arm group label: Neobianacid®
arm group type: Experimental
description: Patients will be provided with enough amount of Omeprazole placebo [30' before meal] and Neobianacid® [30' after meal] (both per os) to complete the first phase of the treatment (day 1-27). Then, at day 28, the patients will be provided with Neobianacid® that can be administered on demand until the study end (day 56). Malgradate will be also provided as rescue medication.
Treatment regimen:
Day 0-13 Breakfast: Omeprazole placebo + Neobianacid® Lunch: Neobianacid® Midafternoon: Neobianacid® Dinner: Neobianacid® Before going to bed: Neobianacid®
Day14-27 Breakfast: Omeprazole placebo + Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed
Day28-55 Breakfast: Neobianacid® on demand Lunch: Neobianacid® on demand Dinner: Neobianacid® on demand Any other time: Neobianacid® on demand, if needed
intervention type: Device
intervention name: Neobianacid®
description: Oral administrations of Neobianacid® (30' after meals and on demand)
arm group label: Neobianacid®
intervention type: Drug
intervention name: Omeprazole 20mg
description: Daily administration Omeprazole 20mg (per os, 30' before breakfast).
arm group label: Omeprazole 20mg
intervention type: Other
intervention name: Neobianacid® placebo
description: Oral administrations of Neobianacid® placebo (30' after meals and on demand)
arm group label: Omeprazole 20mg
intervention type: Other
intervention name: Omeprazole placebo
description: Daily administration Omeprazole placebo (per os, 30' before breakfast).
arm group label: Neobianacid®
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Italy
responsible party type: Sponsor
mesh term: Omeprazole
sharing ipd: No