NCT01303224

Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

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).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 565 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 18 Years – 70 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 the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

Detailed description

The study evaluates the efficacy and safety of three doses of ibodutant, given once daily for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall duration of the study for each patient. Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone based)during all periods of the study.

Conditions

• Irritable Bowel Syndrome With Diarrhea

Interventions

Type	Name	Description
DRUG	Ibodutant	Oral tablet, low dose, once daily, for 8 weeks
DRUG	Ibodutant	Oral tablet, intermediate dose, once daily, for 8 weeks
DRUG	Ibodutant	Oral tablet, high dose, once daily, for 8 weeks
DRUG	Placebo	Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2011-02-24
• Last updated: 2015-10-07
• Results posted: 2013-03-25

Locations

71 sites across 8 countries: Bulgaria, Czechia, Denmark, Germany, Italy, Poland, Spain, Sweden