Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome
Status:
Withdrawn
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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. 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
Phase:
Phase 4
Details
Lead Sponsor:
Tehran University of Medical Sciences
Collaborator:
Tillotts Pharma AG
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination Mesalamine