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

March 20, 2012 updated by: Menarini Group

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).

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

554

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Ballerup, Denmark
        • Center for Clinical and Basic Research (CCBR)
  • Germany
      • Berlin, Germany
        • emovis GmbH
  • Latvia
      • Riga, Latvia
        • Digestive Diseases Center "Gastro"
  • Russian Federation
      • Moscow, Russian Federation
        • Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
  • Ukraine
      • Dnipropetrovsk, Ukraine
        • Academy of Medical Science of Ukraine
  • United Kingdom
      • Birmingham, United Kingdom
        • Synexus Midlands Clinical Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Four weeks
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)
Four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menarini Group

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 20, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAK 03
  • 2008-000214-71 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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