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Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

NCT02959983 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 346

Last updated 2019-02-15

Study results available
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Summary

This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.

Conditions

  • Irritable Bowel Syndrome With Diarrhea

Interventions

DRUG

Eluxadoline

Eluxadoline 100 mg oral tablets BID with food.

DRUG

Placebo

Placebo matching eluxadoline oral tablets BID with food.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Esther Jo · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-10-25
Primary Completion
2018-01-22
Completion
2018-01-22
FDA Drug
Yes

Countries

  • United States
  • Canada

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 NCT02959983 on ClinicalTrials.gov