Trials / Completed
CompletedNCT00730015
Trial of Linaclotide in Patients With Chronic Constipation
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Chronic Constipation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 643 (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each dosing group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Matching Placebo | Oral, once daily |
| DRUG | Linaclotide | Oral, once daily |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-08-01
- Completion
- 2009-10-01
- First posted
- 2008-08-08
- Last updated
- 2013-01-30
- Results posted
- 2013-01-30
Locations
105 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00730015. Inclusion in this directory is not an endorsement.