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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:
Contact: Karen Raudibaugh | 484-321-2123 | kraudibaugh@auxilium.com |
United States, California | |
UCLA School of Medicine | Recruiting |
Burbank, California, United States, 91505 | |
Contact: Alicia Buenrostro 818-843-1700 aliciaresearch@yahoo.com | |
Principal Investigator: Martin Gelbard, MD | |
United States, Connecticut | |
Urology Specialists Connecticut Clinical Research Center, LLC | Recruiting |
Middlebury, Connecticut, United States, 06762 | |
Contact: Brendalie Konopka 203-754-3588 bkonopkaccrcure@aol.com | |
Principal Investigator: Robert Feldman, MD | |
The Urology Center, PC | Recruiting |
New Haven, Connecticut, United States, 06511 | |
Contact: Joanne Wilhelmy 203-789-2222 ext 119 office@urologycenter.com | |
Principal Investigator: Stanton Honig, MD | |
United States, Florida | |
South Florida Medical Research | Recruiting |
Aventura, Florida, United States, 33180 | |
Contact: Sayonara Nunez 305-931-8080 snunez@southfloridamedicalresearch.com | |
Principal Investigator: Marc Gittelman, MD | |
United States, Illinois | |
Urology Specialists, SC | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Terry Klapacz 312-563-3530 tklapcz@hotmail.com | |
Contact: Michelle Villarreal michelledvillarreal@gmail.com | |
Principal Investigator: Laurence Levine, MD | |
United States, Indiana | |
Metropolitan Urology, PSC | Recruiting |
Jeffersonville, Indiana, United States, 47130 | |
Contact: Debbie Johnson 812-288-2611 djohnson@metropolitanurology.com | |
Principal Investigator: James L. Bailen, MD | |
Northeast Indiana Research, LLC | Recruiting |
Fort Wayne, Indiana, United States, 46825 | |
Contact: Susan Wert 260-434-1939 swert@northeastindianaresearch.com | |
Contact: Janet Casperson | |
Principal Investigator: Christopher Steidle, MD | |
United States, New York | |
University Urology Associates | Recruiting |
New York, New York, United States, 10016 | |
Contact: Catherine R Palmero 212-686-9015 ext 29 cpalmero@universityurology.com | |
Principal Investigator: Jed Kaminetsky, MD | |
Maimonides Medical Center Divison of Urology | Recruiting |
Brooklyn, New York, United States, 11219 | |
Contact: Kimberly Prabhu 718-283-7746 kprabhu@maimonides.med.org | |
Principal Investigator: Ridwan Shabsigh, MD | |
United States, Ohio | |
Tristate Urologic Services | Recruiting |
Cincinnati, Ohio, United States, 45212 | |
Contact: William Corbett 513-366-3412 wcorbett@theurologygroup.cc | |
Principal Investigator: Bernard Hertzman, MD | |
United States, Texas | |
Baylor College of Medicine, Scott Department of Urology | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Sharon Harrison, RN 713-798-8517 sharons@bcm.edu | |
Contact: Michael Schumacher, PA 713-798-9140 schumach@bcm.edu | |
Principal Investigator: Larry Lipschultz, MD | |
United States, Virginia | |
Urology of Virginia (a division of Sentara Medical Group) | Recruiting |
Norfolk, Virginia, United States, 23510 | |
Contact: Kim Ramsey, CCRP 757-457-5462 kdramsey@sentara.com | |
Principal Investigator: Gerald Jordan, MD |
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: | November 26, 2008 |
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 |