NCT02107196

12-Week Efficacy and Safety Study of Ibodutant in Women With Irritable Bowel Syndrome With Diarrhea (IBS-D)

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 535 (actual)
• Sponsor: Menarini Group · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12 weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of treatment. The clinical phase of the study comprises up to 2 weeks of screening for patient's eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week safety follow-up, resulting in a maximum 22-week overall duration of the study for each patient. Patients report their IBS-related symptoms daily in a telephone-based electronic diary from run-in until end of treatment.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	Ibodutant 10 mg	Oral tablet, to be given once daily.
DRUG	Placebo	Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-04-08
• Last updated: 2017-01-19
• Results posted: 2016-09-27

Locations

127 sites across 11 countries: United States, Bulgaria, Czechia, France, Germany, Italy, Poland, Romania, Russia, Spain, United Kingdom