Back to resultsIbodutant for Relief of Irritable Bowel Syndrome (IRIS) (IRIS)
Primary Purpose
Irritable Bowel Syndrome
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ibodutant
Ibodutant
Ibodutant
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Bowel disease
Eligibility Criteria
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.
Sites / Locations
- Center for Clinical and Basic Research (CCBR)
- emovis GmbH
- Digestive Diseases Center "Gastro"
- Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
- Academy of Medical Science of Ukraine
- Synexus Midlands Clinical Research Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Ibodutant 10 mg
Ibodutant 30 mg
Ibodutant 60 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00761007
Brief Title
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Acronym
IRIS
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menarini Group
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable Bowel Syndrome, Bowel disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
554 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ibodutant 10 mg
Arm Type
Experimental
Arm Title
Ibodutant 30 mg
Arm Type
Experimental
Arm Title
Ibodutant 60 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15596
Intervention Description
Oral tablet, dose level 1 (10 mg), once daily
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15596
Intervention Description
Oral tablet, dose level 2 (30 mg), once daily
Intervention Type
Drug
Intervention Name(s)
Ibodutant
Other Intervention Name(s)
Code: MEN 15596
Intervention Description
Oral tablet, dose level 3 (60 mg), once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral tablet matching the three dose levels of ibodutant, once daily
Primary Outcome Measure Information:
Title
Response of Overall IBS Symptom Relief - 50% Rule
Description
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)
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Response of Overall IBS Symptom Relief - 75% Rule
Description
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)
Time Frame
Four weeks
Title
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule
Description
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)
Time Frame
Four weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Tack, Professor
Organizational Affiliation
Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Clinical and Basic Research (CCBR)
City
Ballerup
Country
Denmark
Facility Name
emovis GmbH
City
Berlin
Country
Germany
Facility Name
Digestive Diseases Center "Gastro"
City
Riga
Country
Latvia
Facility Name
Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
City
Moscow
Country
Russian Federation
Facility Name
Academy of Medical Science of Ukraine
City
Dnipropetrovsk
Country
Ukraine
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
Country
United Kingdom
12. IPD Sharing Statement
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Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
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