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A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Postoperative Ileus Clinical Trial

Official title:
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00708201
Study type Interventional
Source Cubist Pharmaceuticals LLC
Contact
Status Completed
Phase Phase 4
Start date March 2009
Completion date January 2012
View Details
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