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Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

2014-08-27 03:20:27 | BioPortfolio

Summary

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C).

The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

Study Design

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

Conditions

Irritable Bowel Syndrome With Constipation

Intervention

Linaclotide 300 micrograms, Matching placebo

Location

Forest Investigative Site 036
Birmingham
Alabama
United States
35215

Status

Completed

Source

Forest Laboratories

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:20:27-0400

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Medical and Biotech [MESH] Definitions

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