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

Condition(s) targeted: Postoperative Ileus

Intervention: alvimopan (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Adolor Corporation

Official(s) and/or principal investigator(s):
Lee Techner, DPM, Study Director, Affiliation: Adolor Corporation

Overall contact:
Lee Techner, DPM, Phone: 484-595-1008, Email: ltechner@adolor.com

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

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: 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.

Secondary outcome:

Time to ready for discharge

Time to discharge order written

Length of hospital stay

incidence of adverse events

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

Criteria:

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

Lee Techner, DPM, Phone: 484-595-1008, Email: ltechner@adolor.com

Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States; Recruiting
Justin Deck, CCRC, Phone: 949-305-7008, Email: justindeck@accurateclinicaltrials.net
Arthur Levine, MD, Principal Investigator

University of Colorado Hospital, Aurora, Colorado 80045, United States; Recruiting
Tracey MacDermott, Phone: 303-724-2757, Email: Tracey.MacDermott@UCHSC.edu
Shandra S Wilson, MD, Principal Investigator

University of Miami, Miami, Florida 33136, United States; Recruiting
Angelique V Brown, RN, BSN, CCRC, Phone: 305-243-7207, Email: ABrown3@med.miami.edu
Bruce R Kava, MD, Principal Investigator

H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida 33612, United States; Recruiting
Inez Sims, RN, Phone: 813-745-3982, Email: Inez.Sims@moffitt.org
Wade Sexton, MD, Principal Investigator

University of Chicago, Section of Urology MC6038, Chicago, Illinois 60637, United States; Not yet recruiting
Josephine Silvestre, Phone: 773-702-3080, Email: jsilvest@surgery.bsd.uchicago.edu
Gary D Steinberg, MD, Principal Investigator

The University of Chicago Medical Center, Chicago, Illinois 60637, United States; Recruiting
Josephine Silvestre, RN, MSN, Phone: 773-702-0792, Email: jsilvest@surgery.bsd.uchicago.edu
Gary Steinberg, MD, Principal Investigator

Indiana University Hospital, Indianapolis, Indiana 46202, United States; Recruiting
Cindy Franklin, Phone: 317-274-1798, Email: cf2@iupui.edu
Michael O Koch, MD, Principal Investigator

Ochsner Clinic Foundation, New Orleans, Louisiana 70121, United States; Recruiting
Maria Latsis, Phone: 504-842-3115, Email: mlatsis@ochsner.org
Stephen F Bardot, MD, Principal Investigator

University of Michigan Health System, Ann Arbor, Michigan 48109, United States; Recruiting
Steve Perry, Phone: 734-647-3096, Email: perryste@med.umich.edu
Cheryl T Lee, MD, Principal Investigator

University of Minnesota Hospital, Minneapolis, Minnesota 55455, United States; Recruiting
Mary Jo Hadler, Phone: 612-625-2667, Email: hadle010@umn.edu
Joel Slaton, MD, Principal Investigator

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Carol Van Oort, RN,BSN,CCRP, Phone: 507-284-3369, Email: vanoort.carol@mayo.edu
R. Jeffrey Karnes, MD, Principal Investigator

CRC of Jackson, Jackson, Mississippi 39202, United States; Recruiting
Suzanne Griffith, RN,BSN,CCRC, Phone: 601-714-3261, Email: SGriffith@mbhs.org
Patrick P Daily, MD, Principal Investigator

University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States; Recruiting
Patricia A Robinson, Phone: 919-966-4432, Email: probins@viking.med.unc.edu
Raj S Pruthi, MD, Principal Investigator

Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina 27157, United States; Recruiting
Rachel E Shertzer-Skinner, CCRC, Phone: 336-716-2612, Email: rshertze@wfubmc.edu
A Karim Kader, MD, PhD, Principal Investigator

Cleveland Clinic, Cleveland, Ohio 44195, United States; Recruiting
Angela Hammond-Pickens, Phone: 216-636-9449, Email: hammona@ccf.org
Jerome O'Harra, Jr, MD, Principal Investigator

Bend Memorial Clinic, Bend, Oregon 97701, United States; Recruiting
Pam Gogenola, CMA, CCRC, Phone: 541-318-3168, Email: pgogenola@bmctotalcare.com
Brian O'Hollaren, MD, Principal Investigator

Oregon Health and Science University Knight Cancer Institute, Portland, Oregon 97239, United States; Recruiting
Susan Granat, MA, MAT, Phone: 503-346-0792, Email: granat@ohsu.edu
Siamak Daneshmand, MD, Principal Investigator

Vanderbilt University Medical Center, Department of Urology Surgery, Nashville, Tennessee 37232, United States; Recruiting
Brenda Hughes, RN, CCRC, Phone: 615-343-0445, Email: brenda.hughes@vanderbilt.edu
Sam Chang, MD, Principal Investigator

The University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States; Recruiting
Virginia J Sarmiento, MD, Phone: 713-792-1856, Email: VJSarmiento@mdanderson.org
Ashish M Kamat, MD, Principal Investigator

The Methodist Hospital, Houston, Texas 77030, United States; Recruiting
Susan Kingston, Phone: 713-798-8514, Email: slk@bcm.edu
Gilad E Amiel, MD, Principal Investigator

Starting date: March 2009
Last updated: June 6, 2011