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The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT00755222
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : April 26, 2011
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Peyronie's Disease
Interventions: Biological: AA4500
Biological: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
AA4500 Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
Placebo Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.

Participant Flow:   Overall Study
    AA4500   Placebo
STARTED   111   36 
COMPLETED   103   34 
NOT COMPLETED   8   2 
Withdrawal by Subject                4                2 
Adverse Event                2                0 
Protocol Violation                2                0 



  Baseline Characteristics

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 Clostridial collagenase for injection 0.58 mg. Study drug was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
Placebo Placebo was injected directly into the penile plaque (point of maximal concavity as determined by a standard method) of the flaccid penis. Subjects could recieve up to 3 treatment series. During each treatment series, subjects will receive 2 injections of study drug with at least 24 hours but not more than 72 hours between injections.
Total Total of all reporting groups

Baseline Measures
   AA4500   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 111   36   147 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      95  85.6%      34  94.4%      129  87.8% 
>=65 years      16  14.4%      2   5.6%      18  12.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.9  (7.79)   55.4  (6.95)   56.6  (7.60) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      111 100.0%      36 100.0%      147 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   111   36   147 


  Outcome Measures

1.  Primary:   Change From Baseline in Penile Curvature   [ Time Frame: Baseline and Week 36 or last observation carried forward (LOCF) ]

2.  Primary:   Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother   [ Time Frame: Baseline to Week 36 or LOCF ]

3.  Primary:   Change From Baseline in PDQ Intercourse Contraint   [ Time Frame: Baseline to Week 36 or LOCF ]

4.  Primary:   Change From Baseline in PDQ Intercourse Discomfort   [ Time Frame: Baseline to Week 36 or LOCF ]

5.  Primary:   Change From Baseline in PDQ Penile Pain   [ Time Frame: Baseline to Week 36 or LOCF ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

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: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
e-mail: clinicalsite.inquiries@endo.com



Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00755222     History of Changes
Other Study ID Numbers: AUX-CC-801
First Submitted: September 16, 2008
First Posted: September 18, 2008
Results First Submitted: January 18, 2011
Results First Posted: April 26, 2011
Last Update Posted: October 5, 2017