Trials / Completed
CompletedNCT03573908
A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide 290 μg Administered Orally for 12 Weeks Followed by a 4-week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 614 (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy on abdominal symptoms (abdominal bloating, abdominal discomfort, and abdominal pain) and safety of linaclotide 290 μg administered orally to patients with IBS-C.
Detailed description
This study consists of a 12-week Treatment Period followed by 4-week Randomized Withdrawal (RW) Period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linaclotide | Oral capsule |
| DRUG | Placebo | Matching placebo oral capsule |
Timeline
- Start date
- 2018-06-20
- Primary completion
- 2019-03-13
- Completion
- 2019-04-10
- First posted
- 2018-06-29
- Last updated
- 2020-12-01
- Results posted
- 2020-11-16
Locations
79 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03573908. Inclusion in this directory is not an endorsement.