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

Inclusion Criteria

• •At screening:
• •Female patients aged 18 years or older.
• •Clinical diagnosis of IBS-D according to the following symptoms-based criteria as per Rome III modular questionnaire criteria:
• •1. Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool.
• •2. Symptom-onset at least 6 months prior to diagnosis.
• •3. Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months.
• •4. Additional criterion: 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 a positive family history of colorectal cancer: normal results from colonoscopy/flexible sigmoidoscopy performed within the last 5 years.
• •For patients aged 65 years or older: absence of ischaemic colitis, microscopy colitis or any other organic gastrointestinal disease as evidenced by the results of a colonoscopy/flexible sigmoidoscopy with biopsy performed within 6 months.
• •For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate \<1% per year throughout the entire study period.
• •Physical examination without clinically relevant abnormalities during screening.
• •No clinically relevant abnormalities in 12-Lead ECG or in laboratory findings.
• •Mentally competent, able to give written informed consent, and compliant to undergo all visits and procedures.
• •Unrestricted access to a touch-tone telephone.
• •Willingness to refrain from using loperamide within 3 days prior to run-in visit and during the run-in period.
• •Additional criteria at randomisation:
• •During both weeks of the run-in period:
• •1. A weekly average of worst abdominal pain in the past 24 hours with a score of ≥3.0 on a 0 to 10 point scale.
• •2. At least one bowel movement on each day.
• •3. A weekly average of at least 3 bowel movements per day.
• •4. At least one stool with a consistency of Type 6 or Type 7 according to the Bristol Stool Scale (BSS) on at least 2 days per week.
• •5. Less than 2 bowel movements with a consistency of Type 1 or Type 2 according to the BSS per week.
• •Adequate compliance with the e-diary recording procedure defined as at least 11 of 14 days (≥75%) of the nominal daily data entry.