Ibodutant for Relief of Irritable Bowel Syndrome (IRIS) (IRIS)

• ClinicalTrials.gov Identifier: NCT00761007
• Recruitment Status: Completed
• First Posted: September 26, 2008
• Results First Posted: October 1, 2010
• Last Update Posted: March 21, 2012
• Sponsor: Menarini Group
• Information provided by (Responsible Party): Menarini Group

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Irritable Bowel Syndrome	Drug: Ibodutant; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 554 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: July 2008
• Actual Primary Completion Date: February 2009
• Actual Study Completion Date: March 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ibodutant 10 mg	Drug: Ibodutant; Oral tablet, dose level 1 (10 mg), once daily; Other Name: Code: MEN 15596
Experimental: Ibodutant 30 mg	Drug: Ibodutant; Oral tablet, dose level 2 (30 mg), once daily; Other Name: Code: MEN 15596
Experimental: Ibodutant 60 mg	Drug: Ibodutant; Oral tablet, dose level 3 (60 mg), once daily; Other Name: Code: MEN 15596
Placebo Comparator: Placebo	Drug: Placebo; Oral tablet matching the three dose levels of ibodutant, once daily

Outcome Measures

Primary Outcome Measures :

1. Response of Overall IBS Symptom Relief - 50% Rule [ Time Frame: 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 :

1. Response of Overall IBS Symptom Relief - 75% Rule [ Time Frame: 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)

2. Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Denmark

Center for Clinical and Basic Research (CCBR)

Ballerup, Denmark

Germany

emovis GmbH

Berlin, Germany

Latvia

Digestive Diseases Center "Gastro"

Riga, Latvia

Russian Federation

Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation

Moscow, Russian Federation

Ukraine

Academy of Medical Science of Ukraine

Dnipropetrovsk, Ukraine

United Kingdom

Synexus Midlands Clinical Research Centre

Birmingham, United Kingdom

Sponsors and Collaborators

Menarini Group

Investigators

• Study Chair: Jan Tack, Professor; Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium

More Information

• Responsible Party: Menarini Group
• ClinicalTrials.gov Identifier: NCT00761007
• Other Study ID Numbers: NAK 03; 2008-000214-71 ( EudraCT Number )
• First Posted: September 26, 2008
• Results First Posted: October 1, 2010
• Last Update Posted: March 21, 2012
• Last Verified: March 2012

Keywords provided by Menarini Group:

Irritable Bowel Syndrome; Bowel disease

Additional relevant MeSH terms:

Irritable Bowel Syndrome; Syndrome; Disease; Pathologic Processes; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases