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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cubist Pharmaceuticals LLC
• Treatments: Alvimopan

Criteria

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