CompletedPhase 4

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

United States280 participantsStarted 2009-03

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model

Timeframe: From day of surgery (Day 0) up to 10 days in hospital

Trial details

NCT IDNCT00708201

SponsorCubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

Results submitted2013-09-10

View on ClinicalTrials.gov More Postoperative Ileus trials