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Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Primary Purpose

Diarrhea- Predominant Irritable Bowel Syndrome, Quality of Life

Status

Withdrawn

Phase

Phase 4

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Mesalazine(asacol 800 mg)

Amitriptyline

placebo like asacol

placebo like amitriptyline

About this trial

This is an interventional treatment trial for Diarrhea- Predominant Irritable Bowel Syndrome focused on measuring mesalamine, amitriptyline, Severity of Illness Index

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Establishment of diagnosis of IBS by ROME-III criteria
Age > 18 years old and < 65 years old
Normal colonoscopy or sigmoidoscopy
Negative celiac serologic markers
Normal complete blood count (CBC) and stool exam and stool culture
The patient should not be administered Anti-inflammatory drugs such as Nonsteroidal Antiinflammatory Drugs(NSAIDs), oral or parenteral Antibiotics, Corticosteroids, Mast cell stabilizers, Narcotics, Antidepressants and Immunosuppressive Agents.
Normal thyroid-stimulating hormone (TSH )
Normal Serum Calcium
Educated patient

Exclusion Criteria:

Breast feeding and Pregnancy
Presence of acute or chronic inflammation which can change the basal level of cytokines
Allergic disorders like Asthma (family and personal history)
Presence of organic disease like Diabetes mellitus or Psychiatric disorders.
Alcohol dependency and addiction to Tobacco and Opium
Patients who do not use efficient contraception method
History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy, Hysterectomy and Cesarian-Section
Presence of Celiac disease
History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous year.
History of Cardiac, Pulmonary, Hepatic and Renal disease
Presence of chronic GI disorders
History of Allergy to Aspirin, Mesalamine or Sulpha compounds
History of Lymphocytic or Microscopic Colitis
History of significant weight loss ( 10% of body weight during 6 months), nocturnal sweating, GI bleeding and family history of Colon cancer
Patients with Lactose intolerance disease
Presence of Bowel Acid Malabsorption

Sites / Locations

Gastrointestinal Private Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesalazine(asacol 800 mg)

Amitriptyline

placebo group

Arm Description

patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks

patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks

patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks

Outcomes

Primary Outcome Measures

quality of life

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 .

Secondary Outcome Measures

Serum immune biomarkers

Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.

Full Information

NCT ID

NCT02190526

First Posted

March 27, 2014

Last Updated

April 14, 2016

Sponsor

Tehran University of Medical Sciences

Collaborators

Tillotts Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT02190526

Brief Title

Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

Official Title

Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Study stopped due to lack of volunteer patients.

Study Start Date

September 2014 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tehran University of Medical Sciences

Collaborators

Tillotts Pharma AG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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: Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to Amitriptyline (10 mg/HS) for 8 weeks Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol (800 mg/ TDS) for 8 weeks 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: All patients will fulfill an informed consent Drugs are available without any charge Observation of Helsinki ethical statement

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea- Predominant Irritable Bowel Syndrome, Quality of Life

Keywords

mesalamine, amitriptyline, Severity of Illness Index

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mesalazine(asacol 800 mg)

Arm Type

Experimental

Arm Description

patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks

Arm Title

Amitriptyline

Arm Type

Experimental

Arm Description

patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks

Arm Title

placebo group

Arm Type

Placebo Comparator

Arm 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(s)

Mesalazine(asacol 800 mg)

Intervention Type

Drug

Intervention Name(s)

Amitriptyline

Intervention Type

Drug

Intervention Name(s)

placebo like asacol

Intervention Type

Drug

Intervention Name(s)

placebo like amitriptyline

Primary Outcome Measure Information:

Title

quality of life

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Serum immune biomarkers

Description

Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Establishment of diagnosis of IBS by ROME-III criteria Age > 18 years old and < 65 years old Normal colonoscopy or sigmoidoscopy Negative celiac serologic markers Normal complete blood count (CBC) and stool exam and stool culture The patient should not be administered Anti-inflammatory drugs such as Nonsteroidal Antiinflammatory Drugs(NSAIDs), oral or parenteral Antibiotics, Corticosteroids, Mast cell stabilizers, Narcotics, Antidepressants and Immunosuppressive Agents. Normal thyroid-stimulating hormone (TSH ) Normal Serum Calcium Educated patient Exclusion Criteria: Breast feeding and Pregnancy Presence of acute or chronic inflammation which can change the basal level of cytokines Allergic disorders like Asthma (family and personal history) Presence of organic disease like Diabetes mellitus or Psychiatric disorders. Alcohol dependency and addiction to Tobacco and Opium Patients who do not use efficient contraception method History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy, Hysterectomy and Cesarian-Section Presence of Celiac disease History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous year. History of Cardiac, Pulmonary, Hepatic and Renal disease Presence of chronic GI disorders History of Allergy to Aspirin, Mesalamine or Sulpha compounds History of Lymphocytic or Microscopic Colitis History of significant weight loss ( 10% of body weight during 6 months), nocturnal sweating, GI bleeding and family history of Colon cancer Patients with Lactose intolerance disease Presence of Bowel Acid Malabsorption

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nasser Ebrahimi Daryani, Professor

Organizational Affiliation

Tehran University of Medical Science

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Zahra Azizi, Researcher

Organizational Affiliation

Iran University of Medical Sciences

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mohammad Bashashati, Research Associate

Organizational Affiliation

University of Calgary

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Nima Rezaei, Assistant Professor

Organizational Affiliation

Tehran University Of Medical Science

Official's Role

Study Director

Facility Information:

Facility Name

Gastrointestinal Private Clinic

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

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Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

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