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Sponsored by: |
Auxilium Pharmaceuticals |
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Information provided by: | Auxilium Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00755222 |
This study will evaluate the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease
Condition | Intervention | Phase |
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Peyronie's Disease |
Biological: AA4500 Biological: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Study of the Safety and Effectiveness of AA4500 Administered Two Times a Week for Up to Three Treatment Cycles (2 x 3) in Subjects With Peyronie's Disease |
Estimated Enrollment: | 120 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AA4500: Experimental
Clostridial collagenase for injection
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Biological: AA4500
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.
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Placebo: Placebo Comparator |
Biological: 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.
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A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease.
During the screening period, subjects will have 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 will be recorded.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following conditions:
United States, California | |
UCLA School of Medicine | |
Burbank, California, United States, 91505 | |
United States, Connecticut | |
Urology Specialists Connecticut Clinical Research Center, LLC | |
Middlebury, Connecticut, United States, 06762 | |
The Urology Center, PC | |
New Haven, Connecticut, United States, 06511 | |
United States, Florida | |
South Florida Medical Research | |
Aventura, Florida, United States, 33180 | |
United States, Illinois | |
Urology Specialists, SC | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Metropolitan Urology, PSC | |
Jeffersonville, Indiana, United States, 47130 | |
Northeast Indiana Research, LLC | |
Fort Wayne, Indiana, United States, 46825 | |
United States, New York | |
University Urology Associates | |
New York, New York, United States, 10016 | |
Maimonides Medical Center Divison of Urology | |
Brooklyn, New York, United States, 11219 | |
United States, Ohio | |
Tristate Urologic Services | |
Cincinnati, Ohio, United States, 45212 | |
United States, Texas | |
Baylor College of Medicine, Scott Department of Urology | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Urology of Virginia (a division of Sentara Medical Group) | |
Norfolk, Virginia, United States, 23510 |
Study Director: | John Rodzvilla, MD | Auxilium Pharmaceuticals, Inc. |
Responsible Party: | Auxilium Pharmaceuticals ( John Rodzvilla, MD/Vice President, Medical-Clinical Development ) |
Study ID Numbers: | AUX-CC-801 |
Study First Received: | September 16, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00755222 |
Health Authority: | United States: Food and Drug Administration |
Peyronie's disease penile plaque penile curvature |
Penile Induration Peyronie disease Connective Tissue Diseases Genital Diseases, Male |
Penile Diseases |