Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 3 Arm, 12-Month Study to Evaluate the Effects of GPI 1485 on Erectile Function in Patients Undergoing Bilateral Nerve-Sparing Radical Retropubic Prostatectomy for Prostatic Carcinoma
This drug has been tested in animals, and was shown to protect nerves from damage and to
regrow damaged nerves in these animal studies. Participants will receive either GPI 1485 or
a placebo (inactive pill). Participants will begin study medication 3 full days prior to
their scheduled surgery.
GPI 1485 will be supplied as an oral tablet formulation to men who are candidates for
bilateral nerve-sparing prostatectomies. Participants randomly assigned to receive GPI 1485
will be required to take four tablets four times a day by mouth.
GPI 1485 matching placebo will also be supplied as an oral tablet formulation. Participants
randomly assigned to placebo will be required to take 4 placebo tablets four times a day by
mouth.
Viagra® will be supplied as oral tablets beginning 1 month post-surgery. Patients can begin
Viagra® 1 month post-surgery and may continue use until the end of the study, as needed.
The duration of this study is 12 months which includes 5 office visits to your doctor in
addition to the surgery day. During this study you will also have other clinical
evaluations including a physical exam, blood work, ECG (tracing of your heart rhythm) and
urinalysis.
Participants enrolled in this study will also carry a handheld diary that is loaded with
special protocol-specific software, which will be referred to as the patient experience
diary (PED). Over the duration of this study, participants will complete their
questionnaires and answer questions about their medication compliance in the electronic PED.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Antonella Favit-Van Pelt, MD, PhD
Study Director
Eisai Inc.
United States: Food and Drug Administration
0501-0202
NCT00090376
December 2003
Name | Location |
---|---|
University of Michigan | Ann Arbor, Michigan 48109-0624 |
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Madigan Army Medical Center | Tacoma, Washington 98431-5048 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Columbia University | New York, New York 10032-3784 |
Duke University Medical Center | Durham, North Carolina 27710 |
Center for Urological Research | La Mesa, California 91942 |
The Cleveland Clinic Foundation | Cleveland, Ohio |
Urological Associates of Lancaster, Ltd. | Lancaster, Pennsylvania 17604 |
Tulane University Health Sciences Center | New Orleans, Louisiana 70112 |
Connecticut Surgical Group | Hartford, Connecticut 06106 |
Carolina Urologic Research Center | Myrtle Beach, South Carolina 29572 |
Connecticut Urological Research at Grove Hill | New Britain, Connecticut 06052 |
The University of Texas Health Science Center at San Antonio | San Antonio, Texas 78229 |
HOPE Research Institute, LLC | Phoenix, Arizona 85032 |
Johns Hopkins Hospital | Baltimore, Maryland 21287 |
Henry Ford Health System, Vattikuti Institute for Urology | Detroit, Michigan 48202 |
PPS Clinical Research, St. Louis | St. Louis, Missouri 63141 |
NYU Urology Associates | New York, New York 10016 |
Carolinas Health Care System McKay Urology | Charlotte, North Carolina 28204 |
Vanderbilt Medical Center | Nashville, Tennessee 37232-2765 |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |