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Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT00761007
First received: September 25, 2008
Last updated: March 20, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Irritable Bowel Syndrome
 Drug: Ibodutant
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Further study details as provided by Menarini Group:

Primary Outcome Measures:
  • Response of Overall IBS Symptom Relief - 50% Rule [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

    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:
  • Response of Overall IBS Symptom Relief - 75% Rule [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

    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 [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

    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)



Enrollment: 554
Study Start Date: July 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00761007

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

No publications provided

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT00761007     History of Changes
Other Study ID Numbers: NAK 03, 2008-000214-71
Study First Received: September 25, 2008
Results First Received: September 8, 2010
Last Updated: March 20, 2012
Health Authority: Italy: Ethics Committee
Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Latvia: State Agency of Medicines
Denmark: Danish Medicines Agency
Slovakia: State Institute for Drug Control
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by Menarini Group:
Irritable Bowel Syndrome
Bowel disease

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013