Trials / Completed
CompletedNCT03097861
Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 552 (actual)
- Sponsor
- Sucampo Pharma Americas, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lubiprostone | 24 mcg administered orally BID |
| DRUG | Placebo | 24 mcg administered orally BID |
Timeline
- Start date
- 2017-03-13
- Primary completion
- 2017-08-17
- Completion
- 2017-08-17
- First posted
- 2017-03-31
- Last updated
- 2020-01-14
- Results posted
- 2020-01-14
Locations
67 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03097861. Inclusion in this directory is not an endorsement.