Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

NCT02190526 | Withdrawn Phase 4 DMC

• 1 other identifier: 8811215278
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Diarrhea- Predominant Irritable Bowel Syndrome; Quality of Life

Keywords

mesalamine; amitriptyline; Severity of Illness Index

Outcome Measures

Primary Outcomes (1)

• 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 .

  1 year

Secondary Outcomes (1)

• Serum immune biomarkers

  1 year

Study Arms (3)

Mesalazine(asacol 800 mg)

EXPERIMENTAL

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

Drug: Mesalazine(asacol 800 mg); Drug: placebo like amitriptyline

Amitriptyline

EXPERIMENTAL

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

Drug: Amitriptyline; Drug: placebo like asacol

placebo group

PLACEBO COMPARATOR

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

Drug: placebo like asacol; Drug: placebo like amitriptyline

Interventions

Mesalazine(asacol 800 mg) DRUG

Mesalazine(asacol 800 mg)

Amitriptyline DRUG

Amitriptyline

placebo like asacol DRUG

Amitriptyline; placebo group

placebo like amitriptyline DRUG

Mesalazine(asacol 800 mg); placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Tillotts Pharma AG: collaborator

Study Sites (1)

Gastrointestinal Private Clinic

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

Amitriptyline

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Nasser Ebrahimi Daryani, Professor

  Tehran University of Medical Science

  STUDY DIRECTOR

• Zahra Azizi, Researcher

  Iran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mohammad Bashashati, Research Associate

  University of Calgary

  STUDY DIRECTOR

• Nima Rezaei, Assistant Professor

  Tehran University Of Medical Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: July 15, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 15, 2016

Record last verified: 2016-04

Locations

IR (1)