A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
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
- to evaluate the overall and cardiovascular safety of alvimopan
Study Status: Completed
Information provided by:
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, Ohio 44195
Lee Techner, DPM., Study Director