CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 565 enrolled
Drug / intervention
Ibodutant +3 moredrug
Likely dose
Not stated in 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.

Search/NCT01303224
NCT01303224Phase 2Completed
CompareCT.gov

Double-blind, Randomised, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Effect of Oral Ibodutant in Irritable Bowel Syndrome With Diarrhoea (IBS-D).

Menarini Group·interventional·Posted Feb 24, 2011·Updated Oct 7, 2015

In Brief

A Phase 2 clinical trial evaluating Ibodutant and Placebo for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 565 participants across 71 sites in 8 countries.

Detailed Summary

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesBulgaria, Czechia, Denmark, Germany, Italy, Poland, Spain, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 24, 2011
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.4 years ago

Interventions

Ibodutantdrug

Oral tablet, low dose, once daily, for 8 weeks

Ibodutantdrug

Oral tablet, intermediate dose, once daily, for 8 weeks

Ibodutantdrug

Oral tablet, high dose, once daily, for 8 weeks

Placebodrug

Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks