Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00090376
Status:
COMPLETED
Last Update Posted:
2008-11-07
First Post:
2004-08-25
Brief Title:
Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
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
Status Verified Date:
2008-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None