<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/NCT02190526</url>
  </required_header>
  <id_info>
    <org_study_id>8811215278</org_study_id>
    <nct_id>NCT02190526</nct_id>
  </id_info>
  <brief_title>Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome</brief_title>
  <official_title>Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tehran University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Tillotts Pharma AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tehran University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the&#xD;
      Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable&#xD;
      Bowel Syndrome (IBS-D).&#xD;
&#xD;
      All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) ,&#xD;
      Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the&#xD;
      beginning of trial and at weeks 2,4,6 and 8 of treatment.&#xD;
&#xD;
      Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a&#xD;
      clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for&#xD;
      the first time to our private gastrointestinal clinic from 2014 until 2016.&#xD;
&#xD;
      All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In&#xD;
      order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for&#xD;
      14 days before inclusion and patients whose symptoms improve by this regimen will be&#xD;
      excluded.&#xD;
&#xD;
      This trial is a double-blind study and all patients will be assigned randomly to three&#xD;
      groups:&#xD;
&#xD;
        1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to&#xD;
           Amitriptyline (10 mg/HS) for 8 weeks&#xD;
&#xD;
        2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol&#xD;
           (800 mg/ TDS) for 8 weeks&#xD;
&#xD;
        3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and&#xD;
           placebo similar to Amitriptyline (10 mg/HS) for 8 weeks&#xD;
&#xD;
      Ethical considerations:&#xD;
&#xD;
        1. All patients will fulfill an informed consent&#xD;
&#xD;
        2. Drugs are available without any charge&#xD;
&#xD;
        3. Observation of Helsinki ethical statement&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study stopped due to lack of volunteer patients.&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quality of life</measure>
    <time_frame>1 year</time_frame>
    <description>All patients will fill three validated questionnaires (IBS-SSS , HADS and IBS-QOL ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment to assess quality of life and symptom severity scale in patients with diarrhea- predominant .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum immune biomarkers</measure>
    <time_frame>1 year</time_frame>
    <description>Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Diarrhea- Predominant Irritable Bowel Syndrome</condition>
  <condition>Quality of Life</condition>
  <arm_group>
    <arm_group_label>Mesalazine(asacol 800 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Amitriptyline</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mesalazine(asacol 800 mg)</intervention_name>
    <arm_group_label>Mesalazine(asacol 800 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amitriptyline</intervention_name>
    <arm_group_label>Amitriptyline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo like asacol</intervention_name>
    <arm_group_label>Amitriptyline</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo like amitriptyline</intervention_name>
    <arm_group_label>Mesalazine(asacol 800 mg)</arm_group_label>
    <arm_group_label>placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Establishment of diagnosis of IBS by ROME-III criteria&#xD;
&#xD;
          2. Age &gt; 18 years old and &lt; 65 years old&#xD;
&#xD;
          3. Normal colonoscopy or sigmoidoscopy&#xD;
&#xD;
          4. Negative celiac serologic markers&#xD;
&#xD;
          5. Normal complete blood count (CBC) and stool exam and stool culture&#xD;
&#xD;
          6. The patient should not be administered Anti-inflammatory drugs such as Nonsteroidal&#xD;
             Antiinflammatory Drugs(NSAIDs), oral or parenteral Antibiotics, Corticosteroids, Mast&#xD;
             cell stabilizers, Narcotics, Antidepressants and Immunosuppressive Agents.&#xD;
&#xD;
          7. Normal thyroid-stimulating hormone (TSH )&#xD;
&#xD;
          8. Normal Serum Calcium&#xD;
&#xD;
          9. Educated patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Breast feeding and Pregnancy&#xD;
&#xD;
          2. Presence of acute or chronic inflammation which can change the basal level of&#xD;
             cytokines&#xD;
&#xD;
          3. Allergic disorders like Asthma (family and personal history)&#xD;
&#xD;
          4. Presence of organic disease like Diabetes mellitus or Psychiatric disorders.&#xD;
&#xD;
          5. Alcohol dependency and addiction to Tobacco and Opium&#xD;
&#xD;
          6. Patients who do not use efficient contraception method&#xD;
&#xD;
          7. History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy,&#xD;
             Hysterectomy and Cesarian-Section&#xD;
&#xD;
          8. Presence of Celiac disease&#xD;
&#xD;
          9. History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous&#xD;
             year.&#xD;
&#xD;
         10. History of Cardiac, Pulmonary, Hepatic and Renal disease&#xD;
&#xD;
         11. Presence of chronic GI disorders&#xD;
&#xD;
         12. History of Allergy to Aspirin, Mesalamine or Sulpha compounds&#xD;
&#xD;
         13. History of Lymphocytic or Microscopic Colitis&#xD;
&#xD;
         14. History of significant weight loss ( 10% of body weight during 6 months), nocturnal&#xD;
             sweating, GI bleeding and family history of Colon cancer&#xD;
&#xD;
         15. Patients with Lactose intolerance disease&#xD;
&#xD;
         16. Presence of Bowel Acid Malabsorption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nasser Ebrahimi Daryani, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Tehran University of Medical Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zahra Azizi, Researcher</last_name>
    <role>Principal Investigator</role>
    <affiliation>Iran University of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohammad Bashashati, Research Associate</last_name>
    <role>Study Director</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nima Rezaei, Assistant Professor</last_name>
    <role>Study Director</role>
    <affiliation>Tehran University Of Medical Science</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gastrointestinal Private Clinic</name>
      <address>
        <city>Tehran</city>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>March 27, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>April 14, 2016</last_update_submitted>
  <last_update_submitted_qc>April 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mesalamine</keyword>
  <keyword>amitriptyline</keyword>
  <keyword>Severity of Illness Index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Irritable Bowel Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mesalamine</mesh_term>
    <mesh_term>Amitriptyline</mesh_term>
  </intervention_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/NCT02190526
org study id: 8811215278
nct id: NCT02190526
lead sponsor: 
collaborator: 
has dmc: Yes
The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the
      Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable
      Bowel Syndrome (IBS-D).

      All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) ,
      Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the
      beginning of trial and at weeks 2,4,6 and 8 of treatment.

      Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a
      clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for
      the first time to our private gastrointestinal clinic from 2014 until 2016.

      All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In
      order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for
      14 days before inclusion and patients whose symptoms improve by this regimen will be
      excluded.

      This trial is a double-blind study and all patients will be assigned randomly to three
      groups:

        1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to
           Amitriptyline (10 mg/HS) for 8 weeks

        2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol
           (800 mg/ TDS) for 8 weeks

        3. Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and
           placebo similar to Amitriptyline (10 mg/HS) for 8 weeks

      Ethical considerations:

        1. All patients will fulfill an informed consent

        2. Drugs are available without any charge

        3. Observation of Helsinki ethical statement
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: quality of life
time frame: 1 year
description: All patients will fill three validated questionnaires (IBS-SSS , HADS and IBS-QOL ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment to assess quality of life and symptom severity scale in patients with diarrhea- predominant .
measure: Serum immune biomarkers
time frame: 1 year
description: Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.
arm group label: Mesalazine(asacol 800 mg)
arm group type: Experimental
description: patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks
arm group label: Amitriptyline
arm group type: Experimental
description: patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks
arm group label: placebo group
arm group type: Placebo Comparator
description: patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks
intervention type: Drug
intervention name: Mesalazine(asacol 800 mg)
arm group label: Mesalazine(asacol 800 mg)
intervention type: Drug
intervention name: Amitriptyline
arm group label: Amitriptyline
intervention type: Drug
intervention name: placebo like asacol
arm group label: Amitriptyline
arm group label: placebo group
intervention type: Drug
intervention name: placebo like amitriptyline
arm group label: Mesalazine(asacol 800 mg)
arm group label: placebo group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Nasser Ebrahimi Daryani, Professor
role: Study Director
affiliation: Tehran University of Medical Science
last name: Zahra Azizi, Researcher
role: Principal Investigator
affiliation: Iran University of Medical Sciences
last name: Mohammad Bashashati, Research Associate
role: Study Director
affiliation: University of Calgary
last name: Nima Rezaei, Assistant Professor
role: Study Director
affiliation: Tehran University Of Medical Science
facility: 
country: Iran, Islamic Republic of
responsible party type: Sponsor
mesh term: Irritable Bowel Syndrome
mesh term: Syndrome
mesh term: Diarrhea
mesh term: Mesalamine
mesh term: Amitriptyline