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Ibodutant for Relief of Irritable Bowel Syndrome (IRIS) — IRIS  

Irritable Bowel Syndrome Clinical Trial

Official title:
Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Effect of a 4-week Treatment With Oral Doses of Ibodutant (Code: MEN15596) in Irritable Bowel Syndrome (IBS).

Clinical Trial Summary

The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.

Clinical Trial Description

Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00761007
Study type Interventional
Source Menarini Group
Contact
Status Completed
Phase Phase 2
Start date July 2008
Completion date March 2009
View Details
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