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

NCT02190526 Phase 4 WITHDRAWN

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

Details

Lead sponsor	Tehran University of Medical Sciences
Phase	Phase 4
Status	WITHDRAWN
Start date	2014-09
Completion	2015-12

Conditions

• Diarrhea- Predominant Irritable Bowel Syndrome
• Quality of Life

Interventions

• Mesalazine(asacol 800 mg)
• Amitriptyline
• placebo like asacol
• placebo like amitriptyline

Primary outcomes

• quality of life — 1 year
  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 .

Countries

Iran