Conditions: Irritable Bowel Syndrome With Diarrhea
Keywords: Irritable Bowel Syndrome Colon, irritable Bowel disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 565
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Oral tablet, to be given once daily in fasting conditions. arm 2: Oral tablet, to be given once daily in fasting conditions. arm 3: Oral tablet, to be given once daily in fasting conditions. arm 4: Oral tablet, to be given once daily in fasting conditions.

Interventions: intervention 1: Ibodutant intervention 2: Ibodutant intervention 3: Ibodutant intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablet, low dose, once daily, for 8 weeks intervention 2: Oral tablet, intermediate dose, once daily, for 8 weeks intervention 3: Oral tablet, high dose, once daily, for 8 weeks intervention 4: Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks

Protocol document: