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A Phase 4, Multicenter, Double-Blind, Placebo-Controlled, Parallel Study of Alvimopan for the Management of Postoperative Ileus in Subjects Undergoing Radical Cystectomy.


Phase 4
18 Years
N/A
Not Enrolling
Both
Postoperative Ileus

Thank you

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 ClinicRochester, Minnesota  55905
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Saddleback Memorial Medical CenterLaguna Hills, California  92653
Bend Memorial ClinicBend, Oregon  97701
The University of Chicago Medical CenterChicago, Illinois  60637-1470
Cleveland ClinicCleveland, Ohio  44195
H. Lee Moffitt Cancer Center & Research InstituteTampa, Florida  33612
University of Colorado HospitalDenver, Colorado  80262
University of MiamiMiami, Florida  33136
The Methodist HospitalHouston, Texas  77030
University of North Carolina HospitalsChapel Hill, North Carolina  27599
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
Indiana University HospitalIndianapolis, Indiana  46202
University of Michigan Health SystemAnn Arbor, Michigan  
University of Chicago, Section of Urology MC6038Chicago, Illinois  60637
University of Minnesota HospitalMinneapolis, Minnesota  55455
CRC of JacksonJackson, Mississippi  39202
Oregon Health and Science University Knight Cancer InstitutePortland, Oregon  97239
Vanderbilt University Medical Center, Department of Urology SurgeryNashville, Tennessee  37232