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

Inclusion Criteria

• •At start of the run-in period:
• •Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the Rome III criteria:
• •Recurrent abdominal pain/discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics:
• •1. improvement with defecation;
• •2. onset associated with a change in the frequency of stool;
• •3. onset associated with a change in form (appearance) of stool.
• •Symptom-onset at least 6 months prior to diagnosis.
• •Loose/watery stools at least 25% of the time in the last 3 months AND hard/lumpy stools less than 25% of the time in the last 3 months.
• •More than 3 bowel movements per day at least 25% of the time in the last 3 months.
• •For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy.
• •Mentally competent, able to give written informed consent.
• •For women of childbearing potential: Use of a highly effective contraceptive method throughout the entire study period and up to 30 days post-treatment.
• •Normal physical examination or without clinically relevant abnormalities.
• •At randomisation:
• •Confirmation of IBS-D severity in terms of bowel movement frequency and abdominal pain intensity along the 2-week run-in period.