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Trial of Linaclotide in Patients With Chronic Constipation | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Trial of Linaclotide in Patients With Chronic Constipation

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation

NCT00730015•Ironwood Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
•Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
•Patient meets protocol criteria for CC: reports \< 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during \> 25% of BMs
•Patient demonstrates continued chronic constipation through Pretreatment Period
•Patient is compliant with IVRS

Exclusion Criteria

•Patient has history of loose or watery stools
•Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
•Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
•Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

Locations (105)

Ironwood Investigational Site

Birmingham, Alabama, United States

Ironwood Investigational Site

Huntsville, Alabama, United States

Ironwood Investigational Site

Chandler, Arizona, United States

Ironwood Investigational Site

Phoenix, Arizona, United States

Ironwood Investigational Site

Tucson, Arizona, United States

Ironwood Investigational Site

Tuscon, Arizona, United States

Ironwood Investigational Site

Sherwood, Arkansas, United States

Ironwood Investigational Site

Anaheim, California, United States

Ironwood Investigational Site

Chula Vista, California, United States

Ironwood Investigational Site

Encinitas, California, United States

Key Dates

Start Date

August 1, 2008

Primary Completion Date

August 1, 2009

Completion Date

October 1, 2009

Last Updated

January 30, 2013

Enrollment

643

ACTUAL participants

Conditions

Chronic Constipation

Interventions

Matching Placebo

DRUG

Linaclotide

DRUG

Exploring the Potential Benefits of Probiotic Yogurt

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Chronic Constipation

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RECRUITINGNA

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ACTIVE_NOT_RECRUITINGNA

"Which Type of Exercise is More Effective in Chronic Constipation?

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trial of Linaclotide in Patients With Chronic Constipation

Inclusion Criteria

Exclusion Criteria

Exploring the Potential Benefits of Probiotic Yogurt

Sacral Neuromodulation as Treatment for Chronic Constipation

"Which Type of Exercise is More Effective in Chronic Constipation?

Validation of New Type Radiopaque Marker in The Evaluation of Colonic Transit Time

Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation

Effectiveness and Safety of Probiotic in Regulating Chronic Constipation