Phase 2
N=554
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Irritable Bowel Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00761007 ↗Enrolled (actual)
554
Serious AEs
0.7%
Results posted
Oct 2010
Primary outcome: Primary: Response of Overall IBS Symptom Relief - 50% Rule — 79; 61; 61; 78 Participants
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
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response of Overall IBS Symptom Relief - 50% Rule |
79; 61; 61; 78 | — |
| SECONDARY Response of Overall IBS Symptom Relief - 75% Rule |
53; 39; 37; 48 | — |
| SECONDARY Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule |
33; 17; 22; 25 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female patients aged 18 - 70 years.
- Clinical diagnosis of IBS .
- For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
- Use of appropriate contraceptive methods.
- Normal physical examination or without clinically relevant abnormalities.
Exclusion Criteria
- Patients with organic abnormalities of the gastro-intestinal tract including history of colonic or major abdominal surgery, current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
- History of gluten enteropathy.
- Lactose intolerance as assessed by response to diet
- Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
- Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
- Unstable medical condition.
- Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
- Pregnancy or breastfeeding.
- Patient not able to understand or collaborate throughout the study.
- Participation in other clinical trials in the previous 4 weeks.
Data sourced from ClinicalTrials.gov (NCT00761007). 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.