Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

Study Overview
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Brief Summary
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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
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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.

Official Title
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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).

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Ibodutant
* Drug: Ibodutant
* Drug: Ibodutant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibodutant 10 mg<br> | Drug: Ibodutant<br>* Oral tablet, dose level 1 (10 mg), once daily<br>* Other names: Code: MEN 15596;|
| Experimental: Ibodutant 30 mg<br> | Drug: Ibodutant<br>* Oral tablet, dose level 2 (30 mg), once daily<br>* Other names: Code: MEN 15596;|
| Experimental: Ibodutant 60 mg<br> | Drug: Ibodutant<br>* Oral tablet, dose level 3 (60 mg), once daily<br>* Other names: Code: MEN 15596;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral tablet matching the three dose levels of ibodutant, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of Overall IBS Symptom Relief - 50% Rule | 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) | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of Overall IBS Symptom Relief - 75% Rule | 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) | Four weeks | 
| Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule | 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) | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Irritable Bowel Syndrome, Bowel disease