Trials / Completed
CompletedNCT00595946
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
- 439 (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.
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
- 2008-01-16
- Last updated
- 2019-12-16
- Results posted
- 2016-02-03
Locations
95 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00595946. Inclusion in this directory is not an endorsement.