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

Completed · Phase 4 · Has a placebo group

Conditions studied: Postoperative Ileus

In brief

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

Key facts

Study ID

NCT00708201

Run by

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

People needed

280

Starts

2009-03-01

Expected to finish

2012-01-01

Last updated by the study team

2016-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Saddleback Memorial Medical Center — Laguna Hills, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• University of Miami — Miami, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Chicago, Section of Urology MC6038 — Chicago, Illinois, United States
• Indiana University Hospital — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• University of Minnesota Hospital — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• CRC of Jackson — Jackson, Mississippi, United States
• University of North Carolina Hospitals — Chapel Hill, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Bend Memorial Clinic — Bend, Oregon, United States
• Oregon Health and Science University Knight Cancer Institute — Portland, Oregon, United States
• Vanderbilt University Medical Center, Department of Urology Surgery — Nashville, Tennessee, United States
• The Methodist Hospital — Houston, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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