CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 535 enrolled
Drug / intervention
Ibodutant 10 mg +1 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.

Search/NCT02107196
NCT02107196Phase 3Completed
CompareCT.gov

A 12-Week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-Week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhea

Menarini Group·interventional·Posted Apr 8, 2014·Updated Jan 19, 2017

In Brief

A Phase 3 clinical trial evaluating Ibodutant 10 mg and Placebo for Irritable Bowel Syndrome With Diarrhea. Completed, enrolled 535 participants across 127 sites in 11 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 oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome With Diarrhea
CountriesBulgaria, Czechia, France, Germany, Italy, Poland, Romania, Russia, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 8, 2014
Enrollment StartMar 1, 2014
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.2 years ago

Interventions

Ibodutant 10 mgdrug

Oral tablet, to be given once daily.

Placebodrug

Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.