Completed
PHASE2
INTERVENTIONAL
NCT00460811
Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to determine the safety, efficacy, and dose response of a range of oral doses of linaclotide administered to patients meeting criteria for IBS-C.
Interventions
Name:
Linaclotide Acetate
Type:
DRUG
Description:
Oral, once daily
Name:
Matching placebo
Type:
DRUG
Description:
Oral, once daily
Primary Outcomes
Measure:
Change From Baseline in the Weekly Normalized Complete Spontaneous Bowel Movement (CSBM) Rate During Weeks 1 Through 12 of the Treatment Period
TimeFrame:
Change from Baseline to Week 12
Description:
The change in the weekly normalized CSBM Rate during Weeks 1 through 12 of the Treatment Period from the weekly normalized CSBM Rate obtained during the Pretreatment Period.
The CSBM rate was normalized based on the number of CSBMs occurring in that week, adjusting for differences in the duration of the week and black-out periods (time not covered due to a missed IVRS call) versus 7x24 hours.
Trial Information
NCT ID
NCT00460811
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Ironwood Pharmaceuticals, Inc.
Last Updated
December 15, 2025