At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 554 enrolled
Drug / intervention
Ibodutant +3 moredrug
Likely dose
Ibodutant 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 2 clinical trial evaluating Ibodutant and Placebo for Irritable Bowel Syndrome. Completed, enrolled 554 participants across 6 sites in 6 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesDenmark, Germany, Latvia, Russia, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2008
First PostedSep 2008
Primary CompletionFeb 2009
Study CompletionMar 2009
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartJul 1, 2008
Primary CompletionFeb 1, 2009
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 17.8 years ago
Interventions
Ibodutantdrug
Oral tablet, dose level 1 (10 mg), once daily
Ibodutantdrug
Oral tablet, dose level 2 (30 mg), once daily
Ibodutantdrug
Oral tablet, dose level 3 (60 mg), once daily
Placebodrug
Oral tablet matching the three dose levels of ibodutant, once daily