Status:
COMPLETED
A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
Lead Sponsor:
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
Postoperative Ileus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00708201
Start Date
March 1 2009
End Date
January 1 2012
Last Update
January 8 2016
Active Locations (20)
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1
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
University of Miami
Miami, Florida, United States, 33136
4
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States, 33612