Study:
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
Rationale:
n/a
Purpose:
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
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Postoperative Ileus |
Drug: alvimopan
Drug: Placebo |
Phase 4 |
Verified by
Cubist Pharmaceuticals
March, 2012
Sponsored by: Cubist Pharmaceuticals
Information provided by: Cubist Pharmaceuticals
ClinicalTrials.gov identifier: NCT00708201
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Lee Techner, DPM., Study Director