Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Condition: Irritable Bowel Syndrome With Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Intervention: Ibodutant; Ibodutant; Ibodutant; Placebo
Intervention description: Oral tablet, low dose, once daily, for 8 weeks; Oral tablet, intermediate dose, once daily, for 8 weeks; Oral tablet, high dose, once daily, for 8 weeks; Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 565.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Irritable Bowel Syndrome; Colon, irritable; Bowel disease

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.
    

Eligibility criteria:

        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.

        Exclusion criteria:

          -  Organic abnormalities of the gastrointestinal tract, including history of colonic or
             major abdominal surgery.

          -  History of gluten enteropathy.

          -  Lactose intolerance as assessed by response to diet.

          -  History of positive tests for ova or parasites, or occult blood in the stool.

          -  Previous diagnosis of diabetes mellitus (either type 1 or 2).

          -  Unstable medical condition.

          -  Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled
             metabolic disease.

          -  Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2
             months.

          -  Use of concurrent medication with drugs known to interfere with gastro-intestinal
             motility or sensitivity.

          -  Pregnancy or breastfeeding.