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) - D5630C00001

Study identifier:ICP-103-307

ClinicalTrials.gov identifier:NCT01880424

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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)

Medical condition

Irritable Bowel Syndrome with Constipation (IBS-C)

Phase

Phase 3

Healthy volunteers

No

Study drug

Placebo, Linaclotide

Sex

All

Actual Enrollment

1722

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2013
Primary Completion Date: 01 May 2015
Study Completion Date: 01 May 2015

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Aug 2016 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

Ironwood Pharmaceuticals, Inc.

Inclusion and exclusion criteria