Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome
• Interventions: Drug: Placebo; Drug: Ibodutant

• Registration Number: NCT00761007
• Lead Sponsor: Menarini Group

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-25
• Study First Submitted QC: 2008-09-25
• Study First Posted: 2008-09-26
• Primary Completion: 2009-02
• Study Completion: 2009-03
• Results First Submitted: 2010-09-08
• Results First Submitted QC: 2010-09-08
• Results First Posted: 2010-10-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-20
• Last Update Posted: 2012-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 554

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ibodutant 10 mg	Ibodutant	-
Ibodutant 30 mg	Ibodutant	-
Ibodutant 60 mg	Ibodutant	-

Primary Outcome Measures

Name	Time	Method
Response of Overall IBS Symptom Relief - 50% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"; Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)

Secondary Outcome Measures

Name	Time	Method
Response of Overall IBS Symptom Relief - 75% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"; Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule	Four weeks	Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?"; Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)

Trial Locations

Locations (6)

Synexus Midlands Clinical Research Centre; 🇬🇧 Birmingham, United Kingdom

Center for Clinical and Basic Research (CCBR); 🇩🇰 Ballerup, Denmark

emovis GmbH; 🇩🇪 Berlin, Germany

Digestive Diseases Center "Gastro"; 🇱🇻 Riga, Latvia

Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation; 🇷🇺 Moscow, Russian Federation

Academy of Medical Science of Ukraine; 🇺🇦 Dnipropetrovsk, Ukraine