Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome Bowel disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 554
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.

Detailed description:
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Ibodutant intervention 2: Ibodutant intervention 3: Ibodutant intervention 4: Placebo
Intervention descriptions: intervention 1: Oral tablet, dose level 1 (10 mg), once daily intervention 2: Oral tablet, dose level 2 (30 mg), once daily intervention 3: Oral tablet, dose level 3 (60 mg), once daily intervention 4: Oral tablet matching the three dose levels of ibodutant, once daily

Protocol document: