NCT00761007

Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 554 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DRUG	Ibodutant	Oral tablet, dose level 1 (10 mg), once daily
DRUG	Ibodutant	Oral tablet, dose level 2 (30 mg), once daily
DRUG	Ibodutant	Oral tablet, dose level 3 (60 mg), once daily
DRUG	Placebo	Oral tablet matching the three dose levels of ibodutant, once daily

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2008-09-26
• Last updated: 2012-03-21
• Results posted: 2010-10-01

Locations

6 sites across 6 countries: Denmark, Germany, Latvia, Russia, Ukraine, United Kingdom