A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy
NCT ID: NCT00708201
Last Updated: 2016-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
280 participants
INTERVENTIONAL
2009-03-31
2012-01-31
Brief Summary
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* 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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Alvimopan
12 milligrams (mg)
Alvimopan, 12mg, capsule. Administered orally. One 30 minutes to 5 hours before the scheduled start of surgery on Day 0, and twice daily beginning on Postoperative Day 1 (POD 1) until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment
Alvimopan
Placebo
300 mg polyethylene glycol in a capsule
Administered orally at least 30 minutes and no later than 5 hours before the scheduled start of surgery on Day 0. On Day 1, a single dose of placebo was given twice a day for a maximum of 7 days in hospital after surgery.
Placebo
Interventions
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Alvimopan
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* are scheduled for radical cystectomy
* are scheduled to receive postoperative pain management with intravenous participant-controlled opioid analgesics
Exclusion Criteria
* have taken more than 3 doses of opioids (oral or parenteral) within 7 days before the day of surgery
18 Years
ALL
No
Sponsors
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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
INDUSTRY
Responsible Party
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Principal Investigators
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Lee Techner, DPM
Role: STUDY_DIRECTOR
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Locations
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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
Countries
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References
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Lee CT, Chang SS, Kamat AM, Amiel G, Beard TL, Fergany A, Karnes RJ, Kurz A, Menon V, Sexton WJ, Slaton JW, Svatek RS, Wilson SS, Techner L, Bihrle R, Steinberg GD, Koch M. Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. Eur Urol. 2014 Aug;66(2):265-72. doi: 10.1016/j.eururo.2014.02.036. Epub 2014 Feb 26.
Other Identifiers
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14CL403
Identifier Type: OTHER
Identifier Source: secondary_id
3753-002
Identifier Type: -
Identifier Source: org_study_id
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