The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00755222|
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : April 26, 2011
Last Update Posted : October 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peyronie's Disease||Biological: AA4500 Biological: Placebo||Phase 2|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
Clostridial collagenase for injection
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.
Other Name: Clostridial collagenase for injection (AA4500)
|Placebo Comparator: 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.
- Change From Baseline in Penile Curvature [ Time Frame: Baseline and Week 36 or last observation carried forward (LOCF) ]Negative change reflects improvement in penile curvature
- Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother [ Time Frame: Baseline to Week 36 or LOCF ]
Peyronie's disease Symptom Bother Scale: 0-20 lower numbers reflect 'less symptom bother'; higher numbers reflect 'more symptom bother'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the symptom bother scale.
- Change From Baseline in PDQ Intercourse Contraint [ Time Frame: Baseline to Week 36 or LOCF ]
Peyronie's disease intercourse contraint Scale: 0-12 lower numbers reflect 'less intercourse contraint'; higher numbers reflect 'more intercourse constraint'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse constraint scale.
- Change From Baseline in PDQ Intercourse Discomfort [ Time Frame: Baseline to Week 36 or LOCF ]
Peyronie's disease intercourse discomfort Scale: 0-15 lower numbers reflect 'less intercourse discomfort'; higher numbers reflect 'more intercourse discomfort'
Change from baseline equals Week 36 minus baseline. Negative change reflects improvement in the intercourse discomfort scale.
- Change From Baseline in PDQ Penile Pain [ Time Frame: Baseline to Week 36 or LOCF ]Peyronie's disease penile pain Scale: 0-40 lower numbers reflect 'less penile pain'; higher numbers reflect 'more penile pain' Change from baseline=Week 36 minus baseline. Negative change reflects improvement in the penile pain scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00755222
|United States, California|
|Urology Associates Medical Group|
|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|
|Northeast Indiana Research, LLC|
|Fort Wayne, Indiana, United States, 46825|
|Metropolitan Urology, PSC|
|Jeffersonville, Indiana, United States, 47130|
|United States, New York|
|Maimonides Medical Center Divison of Urology|
|Brooklyn, New York, United States, 11219|
|University Urology Associates|
|New York, New York, United States, 10016|
|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, 23502|
|Study Director:||Veronica Urdaneta, MD||Endo Pharmaceuticals|