Trials / Completed
CompletedNCT00597428
Opioid-induced Bowel Dysfunction Pivotal Assessment of Lubiprostone
A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 437 (actual)
- Sponsor
- Sucampo Pharma Americas, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Lubiprostone | 24 mcg capsules twice daily (BID) |
| DRUG | Placebo | 0 mcg capsules twice daily (BID) |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2009-03-01
- Completion
- 2009-03-01
- First posted
- 2008-01-18
- Last updated
- 2019-12-10
- Results posted
- 2015-12-07
Locations
114 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00597428. Inclusion in this directory is not an endorsement.