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Trial of Linaclotide in Patients With Chronic Constipation

NCT00730015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 643

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 dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.

Conditions

  • Chronic Constipation

Interventions

DRUG

Matching Placebo

Oral, once daily

DRUG

Linaclotide

Oral, once daily

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
2008-08-31
Primary Completion
2009-08-31
Completion
2009-10-31

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 NCT00730015 on ClinicalTrials.gov