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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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