Irritable Bowel Syndrome With Constipation (IBS-C) Clinical Trial
Official title:
A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
This clinical trial is an international, multicenter, randomized, double-blind,
placebo-controlled, parallel-group trial comparing one dose of linaclotide to placebo.
Approximately 800 patients with a diagnosis of IBS-C (modified Rome III criteria) will be
randomized at up to 60 trial centers in China, Australia, and New Zealand.
The trial will consist of up to 21 days of screening, 14 to 21 days of pre-treatment, 12
weeks of double-blind treatment, and 2 weeks of follow-up. At the end of the Pre-treatment
Period, patients meeting the entry criteria for this trial will be randomized to one of two
double-blind treatment groups: 290 ug linaclotide, or placebo (1:1).
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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