Clinical Trial: Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 S

Brief 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 Summary: 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.
Sponsor: Menarini Group

Current Primary Outcome: Response of Overall IBS Symptom Relief - 50% Rule [ Time Frame: Four weeks ]

Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"

Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)



Original Primary Outcome: Patient's global assessment of IBS symptoms and abdominal pain/discomfort. [ Time Frame: every week ]

Current Secondary Outcome:

  • Response of Overall IBS Symptom Relief - 75% Rule [ Time Frame: Four weeks ]

    Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"

    Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)

  • Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule [ Time Frame: Four weeks ]

    Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"

    Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)



Original Secondary Outcome: Safety and tolerability of a 4-week oral Ibodutant treatment. [ Time Frame: every two weeks ]

Information By: Menarini Group

Dates:
Date Received: September 25, 2008
Date Started: July 2008
Date Completion:
Last Updated: March 20, 2012
Last Verified: March 2012