NCT00765882

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

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 633 (actual)
• Sponsor: Forest Laboratories · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2008-09-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-10-03
• Last updated: 2013-01-30
• Results posted: 2013-01-30

Locations

108 sites across 2 countries: United States, Canada