Phase 2
N=565
Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)
Irritable Bowel Syndrome With Diarrhea
Bottom Line
View on ClinicalTrials.gov: NCT01303224 ↗Enrolled (actual)
565
Serious AEs
0.9%
Results posted
Mar 2013
Primary outcome: Primary: Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). — 45; 46; 55; 39 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibodutant (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT). |
45; 46; 55; 39; 95; 92 | <0.05 sig |
| SECONDARY Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population |
72; 61; 74; 55; 68; 77 | <0.05 sig |
| SECONDARY Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire) |
56.4; 58.2; 57.2; 58.7; 71.3; 72.1 | — |
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:
- improvement with defecation;
- onset associated with a change in the frequency of stool;
- 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.
Data sourced from ClinicalTrials.gov (NCT01303224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.