A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
18 Years
N/A
Both
Postoperative Ileus
Trial Information
A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.
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
patient-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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Time to achieve recovery of both upper and lower GI function as measured by a composite endpoint of time to the first bowel movement and time to tolerate first solid food. This endpoint is referred to as GI2.
Outcome Time Frame:
up to 10 days
Safety Issue:
No
Principal Investigator
Lee Techner, DPM
Investigator Role:
Study Director
Investigator Affiliation:
Cubist Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
14CL403
NCT ID:
NCT00708201
Start Date:
March 2009
Completion Date:
January 2012
Related Keywords:
- Postoperative Ileus
- ileus
- POI
- Ileus
Name | Location |
|---|---|
| Mayo Clinic | Rochester, Minnesota 55905 |
| Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Saddleback Memorial Medical Center | Laguna Hills, California 92653 |
| Bend Memorial Clinic | Bend, Oregon 97701 |
| The University of Chicago Medical Center | Chicago, Illinois 60637-1470 |
| Cleveland Clinic | Cleveland, Ohio 44195 |
| H. Lee Moffitt Cancer Center & Research Institute | Tampa, Florida 33612 |
| University of Colorado Hospital | Denver, Colorado 80262 |
| University of Miami | Miami, Florida 33136 |
| The Methodist Hospital | Houston, Texas 77030 |
| University of North Carolina Hospitals | Chapel Hill, North Carolina 27599 |
| The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
| Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
| Indiana University Hospital | Indianapolis, Indiana 46202 |
| University of Michigan Health System | Ann Arbor, Michigan |
| University of Chicago, Section of Urology MC6038 | Chicago, Illinois 60637 |
| University of Minnesota Hospital | Minneapolis, Minnesota 55455 |
| CRC of Jackson | Jackson, Mississippi 39202 |
| Oregon Health and Science University Knight Cancer Institute | Portland, Oregon 97239 |
| Vanderbilt University Medical Center, Department of Urology Surgery | Nashville, Tennessee 37232 |
