ImpotencePhase 2NCT00090376
Evaluate the Effects of GPI 1485 on Erectile Function Following Bilateral Nerve-Sparing Prostatectomy
A Phase 2 study testing GPI 1485 in people with Impotence and Prostate Cancer, run by Eisai Inc. at 25 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, men only
- Conditions the study is for
- Impotence, Prostate Cancer
- What is being tested?
- GPI 1485
- How many people
- 240 participants
- Where
- 25 sitesUnited States
- Study dates
- Dec 2003to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of localized prostate carcinoma and scheduled to undergo curative surgical resection via bilateral nerve sparing procedure.
- Localized prostate cancer is defined as:
- Gleason score <=7 (<=3 + <=4)
- PSA <=10 off of finasteride (Proscar®) and dutasteride (Avodart®)
- <=T2a stage disease
- Motivated males, 40 to 69 years of age inclusive, and in the opinion of the investigator, are currently in a monogamous, sexually active relationship.
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- Males that have erectile function (EF) (without the use of pharmacotherapy within 30 days prior to screening assessment).
- EF is defined as a score of >=26 on the EF domain of the IIEF questionnaire based on patient experiences over the 4 weeks prior to biopsy.
- Body Mass Index (BMI) within the 18-34.9 kg/m2 range.
- Able to swallow whole tablets equivalent to capsule size 0.
- Available for protocol-specified visits and procedures.
- Informed written consent must be provided prior to any study-specific procedures.
Who cannot join
- Recent history, within 6 months before screening, of drug or alcohol abuse.
- History of peripheral neuropathy.
- History of acute or chronic depression that in the opinion of the investigator may interfere with protocol-specified efficacy measurements.
- History of diabetes that requires use of insulin or oral hypoglycemic agents, myocardial infarction, or cerebrovascular accident.
- History of spinal trauma or surgery to the brain or spinal cord.
- Any medical disability or laboratory abnormality (e.g., serum creatinine > 2.0 mg/dL) that, in the opinion of the Investigator, may interfere with the protocol-specified safety and efficacy measurements, present an unacceptable risk to the patient's well-being, or compromise the patient's ability to provide informed consent.
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- History of pelvic radiation therapy (external beam radiation or brachytherapy).
- Concomitant use of hormonal therapy, vasodilators (nitrates), dutasteride (Avodart®) or finasteride (Proscar®) within the 30 days prior to biopsy and throughout the study.
- Concomitant use of therapeutic agents to treat ED other than those specified in the protocol is not permitted starting at least 30 days prior to biopsy and continuing throughout the study.
- Previous exposure to GPI 1485 (previously AMG-474-00).
- Treatment with an investigational agent within the 30 days before screening or scheduled to receive an investigational agent other than that specified by this protocol during the course of this study.
- Any contraindication to Viagra® use
- Unable to stop the use of inducers or inhibitors of cytochrome P450 (CYP) 3A4 from Baseline until the end of the study.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
University of Michigan
Ann Arbor, Michigan, 48109-0330
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Carolinas Health Care System McKay Urology
Charlotte, North Carolina, 28204
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Henry Ford Health System, Vattikuti Institute for Urology
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Connecticut Surgical Group
Hartford, Connecticut, 06106
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Center for Urological Research
La Mesa, California, 91942
Urological Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, 17604-3200
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Vanderbilt Medical Center
Nashville, Tennessee, 37232-2765
Connecticut Urological Research at Grove Hill
New Britain, Connecticut, 06052-1395
Tulane University Health Sciences Center
New Orleans, Louisiana, 70112
NYU Urology Associates
New York, New York, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017
Columbia University
New York, New York, 10032
HOPE Research Institute, LLC
Phoenix, Arizona, 85032
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University School of Medicine
St Louis, Missouri, 63110
PPS Clinical Research, St. Louis
St Louis, Missouri, 63141
Stanford University Medical Center
Stanford, California, 94305-5118
Madigan Army Medical Center
Tacoma, Washington, 98431-1100
About this study
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
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.
Read the 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
- Being tested
- GPI 1485
- Keywords
- Erectile Dysfunction, Impotence, Prostate Cancer, Prostatectomy
- Medical subject headings
- Erectile Dysfunction, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPI 1485Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2004 (estimated)
- Study startDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImpotenceStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 240 participants
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symphony Neuro Development Company
- Investigators
- Antonella Favit-Van Pelt, MD, PhD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090376
- Sponsor's protocol ID
- 0501-0202
- Status last verified
- Nov 2008
- First submitted
- 25 Aug 2004
- Last updated
- 7 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00090376
- Acronym / sponsor ID
- 0501-0202
- Conditions
- Impotence, Prostate Cancer
- Keywords
- Erectile Dysfunction, Impotence, Prostate Cancer, Prostatectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Symphony Neuro Development Company
- Study start
- Dec 2003
- First posted
- 30 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinical diagnosis of localized prostate carcinoma and scheduled to undergo curative surgical resection via bilateral nerve sparing procedure.
- Localized prostate cancer is defined as:
- Motivated males, 40 to 69 years of age inclusive, and in the opinion of the investigator, are currently in a monogamous, sexually active relationship.
- Males that have erectile function (EF) (without the use of pharmacotherapy within 30 days prior to screening assessment).
- EF is defined as a score of >=26 on the EF domain of the IIEF questionnaire based on patient experiences over the 4 weeks prior to biopsy.
Key exclusion criteria (13 listed)
- Recent history, within 6 months before screening, of drug or alcohol abuse.
- History of peripheral neuropathy.
- History of acute or chronic depression that in the opinion of the investigator may interfere with protocol-specified efficacy measurements.
- History of diabetes that requires use of insulin or oral hypoglycemic agents, myocardial infarction, or cerebrovascular accident.
- History of spinal trauma or surgery to the brain or spinal cord.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPI 1485 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonella Favit-Van Pelt, MD, PhD study director
Eisai Inc.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GPI 1485 in people with Impotence and Prostate Cancer, run by Eisai Inc. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2008.