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Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

NCT01303224 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 565

Last updated 2015-10-07

Study results available
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Summary

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

Ibodutant

Oral tablet, low dose, once daily, for 8 weeks

DRUG

Ibodutant

Oral tablet, intermediate dose, once daily, for 8 weeks

DRUG

Ibodutant

Oral tablet, high dose, once daily, for 8 weeks

DRUG

Placebo

Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks

Sponsors & Collaborators

  • Menarini Group

    lead INDUSTRY

Principal Investigators

  • Jan Tack, Professor · Department of Gastroenterology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, 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
2010-10-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Bulgaria
  • Czechia
  • Denmark
  • Germany
  • Italy
  • Poland
  • Spain
  • Sweden

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 NCT01303224 on ClinicalTrials.gov