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Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

NCT02544152 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2019-12-27

Study results available
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Summary

A study of the efficacy and safety of Lubiprostone in subjects diagnosed with IBS-M/IBS-U.

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Lubiprostone

8 mcg administered orally twice daily (BID)

DRUG

Placebo

Matching placebo, 0 mcg administered orally twice daily (BID)

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Sucampo AG

    collaborator INDUSTRY

  • Sucampo Pharma Americas, LLC

    lead INDUSTRY

Principal Investigators

  • Global Clinical Leader, MD · Mallinckrodt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

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 NCT02544152 on ClinicalTrials.gov