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NCT02291679 Clinical Trial

Trial of Linaclotide in Patients With Chronic Idiopathic Constipation

Chronic Idiopathic Constipation Clinical Trial

Official title:
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02291679
Other study ID # MCP-103-309
Secondary ID
Status Completed
Phase Phase 3
First received November 11, 2014
Last updated August 1, 2016
Start date October 2014
Est. completion date August 2015

Study information
Verified date February 2016
Source Ironwood Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic idiopathic constipation (CIC). 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.

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Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Linaclotide
Oral, once daily
• Matching Placebo
Oral, once daily
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Sponsors (2)
Lead Sponsor Collaborator
Ironwood Pharmaceuticals, Inc. Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complete Spontaneous Bowel Movement (CSBM) Overall Responder A 12-week CSBM Overall Responder is a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that is 3 or greater and increased by 1 or more from baseline. A CSBM is defined as a spontaneous bowel movement (SBM) that is associated with a sense of complete evacuation.
An SBM is defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.		 Change from Baseline to Week 12 No
See also
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Completed NCT01895543 - Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation Phase 3
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