A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2009 |
| End Date: | January 2012 |
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
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
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
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
We found this trial at
20
sites
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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University of Miami A private research university with more than 15,000 students from around the...
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12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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1 Medical Center Blvd
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27103
(336) 716-2011
Wake Forest University Baptist Medical Center Welcome to Wake Forest Baptist Medical Center, a fully...
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