Trials / Completed
CompletedNCT00452335
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 127 (actual)
- Sponsor
- Sucampo Pharma Americas, LLC · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lubiprostone | 12 mcg capsule once daily (QD) |
| DRUG | Lubiprostone | 12 mcg capsule twice daily (BID) |
| DRUG | Lubiprostone | 24 mcg capsule twice daily (BID) |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2008-10-01
- Completion
- 2008-10-01
- First posted
- 2007-03-27
- Last updated
- 2019-12-17
- Results posted
- 2016-08-22
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00452335. Inclusion in this directory is not an endorsement.