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Ibodutant for Relief of Irritable Bowel Syndrome (IRIS)

NCT00761007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 554

Last updated 2012-03-21

Study results available
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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.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Ibodutant

Oral tablet, dose level 1 (10 mg), once daily

DRUG

Ibodutant

Oral tablet, dose level 2 (30 mg), once daily

DRUG

Ibodutant

Oral tablet, dose level 3 (60 mg), once daily

DRUG

Placebo

Oral tablet matching the three dose levels of ibodutant, once daily

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Jan Tack, Professor · Department of Gastroenterology, University Hospital Katholieke Universiteit Leuven, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2009-02-28
Completion
2009-03-31

Countries

  • Denmark
  • Germany
  • Latvia
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00761007 on ClinicalTrials.gov