Efficacy, Safety, and Tolerability of JNJ-27018966 (Eluxadoline) in the Treatment of Irritable Bowel Syndrome With Diarrhea

NCT01130272 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2019-10-22

Study results available
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Summary

The purpose of this study is to determine the efficacy, safety, and tolerability of different doses of JNJ-27018966 (eluxadoline) compared with placebo in the treatment of patients with irritable bowel syndrome with diarrhea (IBS-d).

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Eluxadoline

Tablets, orally, twice daily.

DRUG

Placebo

Matching placebo oral tablets twice daily.

Sponsors & Collaborators

  • Furiex Pharmaceuticals, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-04-28
Primary Completion
2011-07-14
Completion
2011-07-14

Countries

  • United States

Study Locations

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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 NCT01130272 on ClinicalTrials.gov