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.

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

Inclusion Criteria:

• are either Male or Female at least 18 years of age
• are scheduled for radical cystectomy
• are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics

Exclusion Criteria:

• are scheduled for a partial cystectomy
• have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery