NCT00090376

Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: Male
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

In this phase II study, an investigative (not approved by the FDA) drug called GPI 1485 is being assessed to see if it can help preserve erectile function after prostatectomy.

Detailed description

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.

Conditions

• Impotence
• Prostate Cancer

Interventions

Type	Name	Description
DRUG	GPI 1485

Timeline

• Start date: 2003-12-01
• First posted: 2004-08-30
• Last updated: 2008-11-07

Locations

25 sites across 1 country: United States