The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
NCT ID: NCT00755222
Last Updated: 2017-10-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
147 participants
INTERVENTIONAL
2008-08-31
2009-12-31
Brief Summary
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Detailed Description
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During the screening period, subjects had a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data were recorded.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AA4500
Clostridial collagenase for injection
AA4500
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
Placebo
Placebo
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.
Interventions
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AA4500
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series was separated by 6 weeks.
Placebo
2 single injections of study drug per each treatment series up to three treatment series total in study. Each treatment series is separated by 6 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In a stable relationship with a partner/spouse for at least 3 months before screening
* Have a diagnosis of Peyronie's disease for at least 6 months before first dose of study drug
* Have a penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane
* Have functional difficulty related to Peyronie's disease (eg, difficulty with intromission or erectile dysfunction)
* Be judged to be in good health based upon the results of medical history, physical examination and laboratory profile
* Voluntarily sign an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC). The subject must have also signed an authorization form to allow disclosure of his protected health information. The protected health information authorization form and informed consent form may have been an integrated form or may have been separate forms, depending on the institution
* Be able to complete and understand the various rating instruments
Exclusion Criteria
* Severe pain during penile palpation
* Any of the following conditions:
* Chordee in the presence or absence of hypospadias
* Thrombosis of the dorsal penile artery
* Infiltration by a benign or malignant mass resulting in penile curvature
* Infiltration by an infectious agent, such as lymphogranuloma venereum
* Ventral curvature from any cause
* Presence of sexually transmitted disease
* Known Hepatitis B or C
* Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
* Previously undergone surgery for Peyronie's disease
* Penile curvature of less than 30° or greater than 90°
* Failed to have a rigid erection after pharmacological stimulation with a vasoactive injection of Prostaglandin E1 10 to 20 µg, which, in the opinion of the investigator, was sufficient to accurately measure the subject's penile deformity
* Had a calcified plaque as evident by appropriate radiographic evaluation, penile x-ray, or penile ultrasound. Non-contiguous stippling of calcium was acceptable for inclusion
* Had an isolated hourglass deformity of the penis without curvature
* Had the plaque causing curvature of the penis located proximal to the base of the penis, so that the injection of the local anesthetic would have interfered with the injection of AA4500 into the plaque
* Received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
* Received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E (\>500IU), potassium aminobenzoate \[Potaba\], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 4 weeks before the first dose of study drug or plans to use any of these medical therapies at any time during the study
* Used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
* Used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study
* Significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
* Recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
* Unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
* Received an investigational drug or treatment within 30 days before the first dose of study drug
* Allergy to collagenase or any other excipient of AA4500
* Allergy to any concomitant medication required as per the protocol
* Received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug
* Received doxycycline or a tetracycline derivative during the 7 days before each dose of study drug or plans to use these drugs within 2 days after the injection of study drug
* Received any collagenase treatments within 30 days of the first dose of study drug
18 Years
MALE
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Veronica Urdaneta, MD
Role: STUDY_DIRECTOR
Endo Pharmaceuticals
Locations
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Urology Associates Medical Group
Burbank, California, United States
Urology Specialists Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, United States
The Urology Center, PC
New Haven, Connecticut, United States
South Florida Medical Research
Aventura, Florida, United States
Urology Specialists, SC
Chicago, Illinois, United States
Northeast Indiana Research, LLC
Fort Wayne, Indiana, United States
Metropolitan Urology, PSC
Jeffersonville, Indiana, United States
Maimonides Medical Center Divison of Urology
Brooklyn, New York, United States
University Urology Associates
New York, New York, United States
Tristate Urologic Services
Cincinnati, Ohio, United States
Baylor College of Medicine, Scott Department of Urology
Houston, Texas, United States
Urology of Virginia (a division of Sentara Medical Group)
Norfolk, Virginia, United States
Countries
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Other Identifiers
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AUX-CC-801
Identifier Type: -
Identifier Source: org_study_id