Trials / Completed
CompletedNCT00708201
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 280 (actual)
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to determine whether alvimopan can accelerate recovery of gastrointestinal function following radical cystectomy when compared with a placebo. Secondary objectives of the study are: * to evaluate the effect of alvimopan on hospital length of stay * to evaluate the effect of alvimopan on prespecified postoperative ileus (POI)-related morbidities * to evaluate the overall and cardiovascular safety of alvimopan
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alvimopan | |
| DRUG | Placebo |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2008-07-02
- Last updated
- 2016-01-08
- Results posted
- 2015-07-02
Locations
20 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00708201. Inclusion in this directory is not an endorsement.