Trials / Completed
CompletedNCT04110145
Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Sequential, Ascending, Multidose Study to Evaluate the Safety and Efficacy of Linaclotide in Pediatric Participants (Age 2 to 5 Years) With Functional Constipation
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the dose response, safety, and efficacy of linaclotide when compared with placebo in pediatric participants, 2 to 5 years of age, with Functional Constipation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Linaclotide | Linaclotide, capsules, mixed with water and administered orally, once daily in fasted state. |
| DRUG | Placebo | Matching placebo, capsules, mixed with water and administered orally, once daily in fasted state |
Timeline
- Start date
- 2019-10-14
- Primary completion
- 2021-04-20
- Completion
- 2021-04-20
- First posted
- 2019-10-01
- Last updated
- 2022-04-26
- Results posted
- 2022-04-26
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04110145. Inclusion in this directory is not an endorsement.