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A Study of Alvimopan for the Management of Postoperative Ileus in Participants Undergoing Radical Cystectomy

Information source: Cubist Pharmaceuticals Holdings LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Ileus

Intervention: Alvimopan (Drug); Placebo (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Cubist Pharmaceuticals

Official(s) and/or principal investigator(s):
Lee Techner, DPM, Study Director, Affiliation: Cubist Pharmaceuticals Holdings LLC


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


- to evaluate the overall and cardiovascular safety of alvimopan

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Time to Achieve GI2 Analyzed by Kaplan-Meier (KM) Estimates and Cox Proportional Hazards (PH) Model

Secondary outcome:

Mean Time to Ready for Discharge From Hospital Analyzed by KM Estimates and Cox PH Model

Mean Time to Discharge Order Written (DOW) Using KM Estimates

Postoperative Length of Stay (LOS)

Percentage of Participants Considered Postoperative LOS Responders

Percentage of Participants With Postoperative Morbidity (POM)

Percentage of Participants Considered G12 Responders at 5 Cutoff Time Points

Percentage of Participants Considered DOW Responders at 5 Cutoff Time Points

Percentage of Participants With Blinded Adjudicated Cardiovascular (CV) Events


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States

University of Colorado Hospital, Aurora, Colorado 80045, United States

University of Miami, Miami, Florida 33136, United States

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 33612, United States

The University of Chicago Medical Center, Chicago, Illinois 60637, United States

University of Chicago, Section of Urology MC6038, Chicago, Illinois 60637, United States

Indiana University Hospital, Indianapolis, Indiana 46202, United States

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States

University of Michigan Health System, Ann Arbor, Michigan 48109, United States

University of Minnesota Hospital, Minneapolis, Minnesota 55455, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

CRC of Jackson, Jackson, Mississippi 39202, United States

University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States

Cleveland Clinic, Cleveland, Ohio 44195, United States

Bend Memorial Clinic, Bend, Oregon 97701, United States

Oregon Health and Science University Knight Cancer Institute, Portland, Oregon 97239, United States

Vanderbilt University Medical Center, Department of Urology Surgery, Nashville, Tennessee 37232, United States

The Methodist Hospital, Houston, Texas 77030, United States

The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States

Additional Information

Starting date: March 2009
Last updated: June 4, 2015

Page last updated: August 20, 2015

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