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Linaclotide in Chronic Constipation and Abdominal Bloating
NCT01642914Phase 3
Key facts
- Status
- Completed
- Start
- Aug 2012
- Primary completion
- May 2013
- Countries
- 2
- Sponsor
- Forest Laboratories
- Modality
- Peptides
- Drugs
- linaclotide
- Conditions
- chronic constipation
01
Overview
Phase 3, randomised, double-blind trial of linaclotide in chronic constipation (3 arms), sponsored by Forest Laboratories. Primary endpoint: 9/12 Week Complete Spontaneous Bowel Movement 3+1 Responder. Started Aug 2012; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Linaclotide 290 mcg
Oral capsule once daily
Linaclotide 145 mcg
Oral capsule once daily
Placebo
Matching oral capsule once daily
03
Who it enrols
Patients with chronic constipation (<3 bowel movements per week) and prominent abdominal bloating, excluding those with IBS or GI structural abnormalities.
04
Endpoints
Primary
9/12 Week Complete Spontaneous Bowel Movement 3+1 Responder
Secondary
Change From Baseline in 12-Week Abdominal Bloating
Percent Change From Baseline in 12-week Abdominal Bloating
6/12 Week Abdominal Bloating 30% Responder
Change From Baseline in 12-week CSBM Frequency Rate
Change From Baseline in 12-Week SBM Frequency Rate
SBM Within 24 Hours After the First Dose of Investigational Product
Time to Spontaneous Bowel Movement After the First Dose of Investigational Product
Change From Baseline in 12-week Stool Consistency
05
Results
Primary endpoints met
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