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Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT00938717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 805

Last updated 2013-11-05

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

Conditions

  • Irritable Bowel Syndrome With Constipation

Interventions

DRUG

Linaclotide or Matching Placebo

Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial

Sponsors & Collaborators

  • Forest Laboratories

    collaborator INDUSTRY

  • Ironwood Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey M. Johnston, MD, FACP · Ironwood Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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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 NCT00938717 on ClinicalTrials.gov