Study identifier:ICP-103-307
ClinicalTrials.gov identifier:NCT01880424
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Irritable Bowel Syndrome with Constipation (IBS-C)
Phase 3
No
Placebo, Linaclotide
All
1722
Interventional
18 Years +
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2016 by AstraZeneca
AstraZeneca
Ironwood Pharmaceuticals, Inc.
No locations available
Arms | Assigned Interventions |
---|---|
Placebo Comparator: controlled arm | Drug: Placebo matching Placebo Capsules, Oral, once daily |
Experimental: treatment arm | Drug: Linaclotide Linaclotide 290 ug Capsules, Oral, once daily |