Trials / Completed
CompletedNCT02291679
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide (72 ug or 145 ug) Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,223 (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation (CIC). The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement (CSBM) Overall Responder.
Detailed description
The trial also included a 145 ug linaclotide treatment arm (an FDA-approved dose for CIC) as an established positive control to validate the study design.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linaclotide | |
| DRUG | Matching Placebo |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-08-01
- Completion
- 2015-08-01
- First posted
- 2014-11-14
- Last updated
- 2017-06-15
- Results posted
- 2017-05-19
Locations
95 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02291679. Inclusion in this directory is not an endorsement.