<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/NCT03757078</url>
  </required_header>
  <id_info>
    <org_study_id>20364</org_study_id>
    <nct_id>NCT03757078</nct_id>
  </id_info>
  <brief_title>Study to Find Out How Symptoms Severity Changes During the Standard Course of Treatment With the Cream Relief Pro and Suppositories Relief Pro (Active Ingredients Are Fluocortolone + Lidocaine) in Patients Suffering From Twisted and Bulging Veins in the Rectal Area (Acute Hemorrhoids)</brief_title>
  <official_title>Prospective Multicenter Non-interventional Study of Fluocortolone + Lidocaine Formulation in Patients With Acute Hemorrhoids to Evaluate Changes in Symptoms Severity During the Course of Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</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>
      In this study researcher wanted to learn more about the changes of biggest twisted and&#xD;
      bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment&#xD;
      period with the cream Relief Pro and suppositories Relief Pro. The study collected&#xD;
      information on the treatment satisfaction of patients and their physicians with the&#xD;
      prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic&#xD;
      for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">October 20, 2019</completion_date>
  <primary_completion_date type="Actual">October 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of pain (VAS: Visual Analogue Scale)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of bleeding (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of pruritus (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of swelling (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity (amount) of discharge (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of sense of discomfort (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall patient satisfaction with treatment (according to 5-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to onset of analgesic effect after the first use of the drug</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of analgesic effect after the first use of the drug</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient's adherence to recommendations of the Investigator by PRO</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>PRO: Patient Reported Outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Information obtained in the course of questioning about the consumer properties of the study product by PRO</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of hemorrhoids symptoms according to the Sodergren score</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Size of the largest hemorrhoid node measured during a routine examination</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Amount of ReliefPro used based on information provided by the patient to the Investigator</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3</measure>
    <time_frame>Up to 14 days</time_frame>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1000</enrollment>
  <condition>Acute Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Patients with acute hemorrhoids</arm_group_label>
    <description>Patients with acute hemorrhoids of 1-2 stage were prescribed Fluocortolone + Lidocaine by a physician. No drug will be provided to Patient by the Investigator, only prescription order, based on International Nonproprietary name (Fluocortolone + Lidocaine)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relief Pro cream</intervention_name>
    <description>Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.</description>
    <arm_group_label>Patients with acute hemorrhoids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relief Pro rectal suppositories</intervention_name>
    <description>Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice</description>
    <arm_group_label>Patients with acute hemorrhoids</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult male and female patients with acute hemorrhoids from Russia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male &amp; female patients 18 to 65 years old;&#xD;
&#xD;
          -  Patients with acute hemorrhoids 1 and 2 stage (with thrombosis (external, internal,&#xD;
             mixed), including cases with bleeding);&#xD;
&#xD;
          -  Prescription of fluocortolone + lidocaine as a part of routine clinical practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients participating in an investigational program with interventions outside of&#xD;
             routine clinical practice;&#xD;
&#xD;
          -  Hemorrhoid with stage ˃ II;&#xD;
&#xD;
          -  Contraindications for use of Relief PRO in the approved product label;&#xD;
&#xD;
          -  Anemia and/or severe/profuse hemorrhoid bleeding;&#xD;
&#xD;
          -  Surgery in perianal region in anamnesis;&#xD;
&#xD;
          -  Concomitant treatment with antibiotics/antiseptics, antithrombotics, antineoplastic&#xD;
             and/or immunosuppressant;&#xD;
&#xD;
          -  Inflammatory bowel disease;&#xD;
&#xD;
          -  Hepatic diseases in severe and acute stages;&#xD;
&#xD;
          -  Colorectal cancer;&#xD;
&#xD;
          -  Purulent-inflammatory diseases of the perianal region and anal canal;&#xD;
&#xD;
          -  Chronic pulmonary diseases in severe and acute stages.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>State Scientific Center of Coloproctology</name>
      <address>
        <city>Moscow</city>
        <zip>123423</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <link>
    <url>http://clinicaltrials.bayer.com/</url>
    <description>Click here to find results for studies related to Bayer products</description>
  </link>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>October 26, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>October 21, 2020</last_update_submitted>
  <last_update_submitted_qc>October 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 23, 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>Hemorrhoids</mesh_term>
  </condition_browse>
  <!-- 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/NCT03757078
org study id: 20364
nct id: NCT03757078
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study researcher wanted to learn more about the changes of biggest twisted and
      bulging veins in the rectal area (hemorrhoids) and changes of symptoms during a treatment
      period with the cream Relief Pro and suppositories Relief Pro. The study collected
      information on the treatment satisfaction of patients and their physicians with the
      prescribed treatment by using questionnaires. There were 3 visits at the physician's clinic
      for this study: one initial visit and 2 follow-up visits over a period of 2 weeks.
observational model: Cohort
time perspective: Prospective
measure: Severity of pain (VAS: Visual Analogue Scale)
time frame: Up to 14 days
description: Pain was measured on a Visual Analogue Scale (VAS) from 0 (No Pain) to 10 (Maximal Pain).
measure: Severity of bleeding (according to 4-point Likert scale)
time frame: Up to 14 days
description: 4-point Likert scale consisting of: 1 (None), 2 (Minimal), 3 (Moderate) and 4 (Significant).
measure: Severity of pruritus (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Severity of swelling (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Severity (amount) of discharge (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Severity of sense of discomfort (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Overall patient satisfaction with treatment (according to 5-point Likert scale)
time frame: Up to 14 days
description: Likert scale: 1 (Very satisfied), 2 (Satisfied), 3 (Neither satisfied nor dissatisfied), 4 (Dissatisfied) and 5 (Very dissatisfied).
measure: Time to onset of analgesic effect after the first use of the drug
time frame: Up to 14 days
measure: Duration of analgesic effect after the first use of the drug
time frame: Up to 14 days
measure: Patient's adherence to recommendations of the Investigator by PRO
time frame: Up to 14 days
description: PRO: Patient Reported Outcome
measure: Information obtained in the course of questioning about the consumer properties of the study product by PRO
time frame: Up to 14 days
measure: Severity of hemorrhoids symptoms according to the Sodergren score
time frame: Up to 14 days
description: Standardized answer options are given (4 and 5 Likert boxes) and each question gets a score from 0 to 4.
measure: Size of the largest hemorrhoid node measured during a routine examination
time frame: Up to 14 days
measure: Severity of swelling when assessed as part of routine examination (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Severity of bleeding when assessed as part of routine examination (according to 4-point Likert scale)
time frame: Up to 14 days
measure: Amount of ReliefPro used based on information provided by the patient to the Investigator
time frame: Up to 14 days
measure: Overall satisfaction of Investigator with treatment with Relief Pro according Likert scale from 1 to 5 points as measured on Visits 2 and 3
time frame: Up to 14 days
arm group label: Patients with acute hemorrhoids
description: Patients with acute hemorrhoids of 1-2 stage were prescribed Fluocortolone + Lidocaine by a physician. No drug will be provided to Patient by the Investigator, only prescription order, based on International Nonproprietary name (Fluocortolone + Lidocaine)
intervention type: Drug
intervention name: Relief Pro cream
description: Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.
arm group label: Patients with acute hemorrhoids
intervention type: Drug
intervention name: Relief Pro rectal suppositories
description: Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice
arm group label: Patients with acute hemorrhoids
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Russian Federation
url: http://clinicaltrials.bayer.com/
description: Click here to find results for studies related to Bayer products
responsible party type: Sponsor
mesh term: Hemorrhoids