Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

Irritable Bowel Syndrome Clinical Trial

— 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00761007
• Other study ID #: NAK 03
• Secondary ID: 2008-000214-71
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2008
• Last updated: March 20, 2012
• Start date: July 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2012
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeSpain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesLatvia: State Agency of MedicinesDenmark: Danish Medicines AgencySlovakia: State Institute for Drug ControlUkraine: State Pharmacological Center - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 554
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Ibodutant
Oral tablet, dose level 1 (10 mg), once daily
• Ibodutant
Oral tablet, dose level 2 (30 mg), once daily
• Ibodutant
Oral tablet, dose level 3 (60 mg), once daily
• Placebo
Oral tablet matching the three dose levels of ibodutant, once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Countries where clinical trial is conducted

Denmark,  Germany,  Latvia,  Russian Federation,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Four weeks	No
Secondary	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)	Four weeks	No
Secondary	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)	Four weeks	No