Status:
COMPLETED
Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)
Lead Sponsor:
Menarini Group
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 efficac...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00761007
Start Date
July 1 2008
End Date
March 1 2009
Last Update
March 21 2012
Active Locations (6)
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1
Center for Clinical and Basic Research (CCBR)
Ballerup Municipality, Denmark
2
emovis GmbH
Berlin, Germany
3
Digestive Diseases Center "Gastro"
Riga, Latvia
4
Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
Moscow, Russia