Clinical trial NCT00761007: Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Official title: Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Effect of a 4-week Treatment With Oral Doses of Ibodutant (Code: MEN15596) in Irritable Bowel Syndrome (IBS).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Bowel disease
Lead sponsor: Menarini Group
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18 - 70 years.
2. Clinical diagnosis of IBS .
3. For patients older than 50 years or patients with positive family history of colorectal cancer: normal results from colonoscopy or flexible sigmoidoscopy.
4. Use of appropriate contraceptive methods.
5. Normal physical examination or without clinically relevant abnormalities.

Exclusion Criteria:

1. 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.
2. History of gluten enteropathy.
3. Lactose intolerance as assessed by response to diet
4. Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
5. Previous diagnosis of Diabetes Mellitus (either type 1 or 2)
6. Unstable medical condition.
7. Concomitant medication within 7 days prior to screening with drugs known to interfere with gastro-intestinal motility and sensitivity.
8. Pregnancy or breastfeeding.
9. Patient not able to understand or collaborate throughout the study.
10. Participation in other clinical trials in the previous 4 weeks.

Primary outcomes:
measure: Response of Overall IBS Symptom Relief - 50% Rule
timeFrame: Four weeks
Secondary outcomes:
measure: Response of Overall IBS Symptom Relief - 75% Rule
timeFrame: Four weeks
measure: Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule
timeFrame: Four weeks
Other outcomes:
Locations:
city: Ballerup
country: Denmark
facility: Center for Clinical and Basic Research (CCBR)
city: Berlin
country: Germany
facility: emovis GmbH
city: Riga
country: Latvia
facility: Digestive Diseases Center "Gastro"
city: Moscow
country: Russian Federation
facility: Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
city: Dnipropetrovsk
country: Ukraine
facility: Academy of Medical Science of Ukraine
city: Birmingham
country: United Kingdom
facility: Synexus Midlands Clinical Research Centre
Study officials:
affiliation: Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium
name: Jan Tack, Professor
role: STUDY_CHAIR
References: