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Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

NCT00948818 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2013-01-30

Study results available
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Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Conditions

  • Irritable Bowel Syndrome Characterized by Constipation

Interventions

DRUG

Linaclotide 290 micrograms

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

DRUG

Matching placebo

Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

Sponsors & Collaborators

  • Ironwood Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Forest Laboratories

    lead INDUSTRY

Principal Investigators

  • Paul F.C. Eng, PhD · Forest Research Institute, a subsidiary of Forest Laboratories 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
2010-07-31
Completion
2010-08-31

Countries

  • United States
  • Canada

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 NCT00948818 on ClinicalTrials.gov