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Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

NCT00765882 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 633

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 chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

Conditions

  • Chronic Constipation

Interventions

DRUG

Linaclotide 290 micrograms

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

DRUG

Linaclotide 145 micrograms

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

DRUG

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 Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-07-31
Completion
2009-08-31

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 NCT00765882 on ClinicalTrials.gov