A Study of AA4500 in Men With Peyronie's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01243411
First received: November 17, 2010
Last updated: March 31, 2015
Last verified: March 2015
Results First Received: February 4, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peyronie's Disease
Intervention: Biological: AA4500

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Includes all subjects who were enrolled and received at least 1 dose of study drug; subjects who were enrolled but not treated were excluded from the population

Reporting Groups
  Description
AA4500

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)


Participant Flow:   Overall Study
    AA4500  
STARTED     347  
COMPLETED     306  
NOT COMPLETED     41  
Withdrawal by Subject                 18  
Lost to Follow-up                 10  
Adverse Event                 5  
Unknown                 8  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
AA4500

collagenase clostridium histolyticum

AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)


Baseline Measures
    AA4500  
Number of Participants  
[units: participants]
  347  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     289  
>=65 years     58  
Age  
[units: years]
Mean (Standard Deviation)
  56.5  (9.0)  
Gender  
[units: participants]
 
Female     0  
Male     347  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     22  
Not Hispanic or Latino     325  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     4  
White     333  
More than one race     0  
Unknown or Not Reported     8  
Region of Enrollment  
[units: participants]
 
France     13  
United States     102  
Spain     21  
Denmark     42  
Germany     41  
Italy     24  
United Kingdom     17  
New Zealand     54  
Sweden     33  



  Outcome Measures
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1.  Primary:   Percentage Change From Baseline in Penile Curvature   [ Time Frame: Baseline and Week 36 ]

2.  Primary:   Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)   [ Time Frame: Baseline and Week 36 ]

3.  Secondary:   Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ   [ Time Frame: Baseline and Week 36 ]

4.  Secondary:   Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4   [ Time Frame: Baseline and Week 36 ]

5.  Secondary:   A Responder Analysis Based on Subject Overall Global Assessment   [ Time Frame: Week 36 ]

6.  Secondary:   Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)   [ Time Frame: Baseline and Week 36 ]

7.  Secondary:   Change From Baseline in Penile Plaque Consistency   [ Time Frame: Baseline and Week 36 ]

8.  Secondary:   A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score   [ Time Frame: Week 36 ]

9.  Secondary:   Change From Baseline in Penile Length   [ Time Frame: Baseline and Week 36 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Neil H. Shusterman, MD FACP
Organization: Endo Pharmaceuticals Inc.
phone: 484-216-7294
e-mail: shusterman.neil@endo.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243411     History of Changes
Other Study ID Numbers: AUX-CC-802
Study First Received: November 17, 2010
Results First Received: February 4, 2015
Last Updated: March 31, 2015
Health Authority: United States: Food and Drug Administration
Italy: The Italian Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
New Zealand: Medsafe
Germany: BfArM
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Denmark: Danish Medicines Agency
Sweden: Medical Products Agency