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Trial record 83 of 495 for:    penis

A Study of AA4500 in Men With Peyronie's Disease

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ClinicalTrials.gov Identifier: NCT01243411
Recruitment Status : Completed
First Posted : November 18, 2010
Results First Posted : April 15, 2015
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peyronie's Disease
Intervention Biological: AA4500
Enrollment 348
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title AA4500
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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)

Period Title: Overall Study
Started 347
Completed 306
Not Completed 41
Reason Not Completed
Withdrawal by Subject             18
Lost to Follow-up             10
Adverse Event             5
Other             8
Arm/Group Title AA4500
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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)

Overall Number of Baseline Participants 347
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants
<=18 years
0
   0.0%
Between 18 and 65 years
289
  83.3%
>=65 years
58
  16.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 347 participants
56.5  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants
Female
0
   0.0%
Male
347
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants
Hispanic or Latino
22
   6.3%
Not Hispanic or Latino
325
  93.7%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 347 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   0.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
   1.2%
White
333
  96.0%
More than one race
0
   0.0%
Unknown or Not Reported
8
   2.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 347 participants
France 13
United States 102
Spain 21
Denmark 42
Germany 41
Italy 24
United Kingdom 17
New Zealand 54
Sweden 33
1.Primary Outcome
Title Percentage Change From Baseline in Penile Curvature
Hide Description A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the modified intent-to-treat (mITT) population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: percentage of curvature change
-34.4  (25.21)
2.Primary Outcome
Title Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Hide Description Peyronie's disease bother score range 0 (no issue or not at all bothered) to 4 (extremely bothered) on 4 questions; total score range 0 to 16. A decrease in the change from baseline total score in the Peyronie's disease bother domain of the PDQ is indicated by a negative number.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.3  (3.46)
3.Secondary Outcome
Title Change From Baseline in the Severity of Peyronie's Disease Symptoms Domain of the PDQ
Hide Description Peyronie's disease symptoms (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions; total score range 0 to 24. A decrease in the change from baseline total score in the Peyronie's disease symptoms domain of the PDQ is indicated by a negative number.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.2  (5.14)
4.Secondary Outcome
Title Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
Hide Description Penile pain scale range 0 (no pain) to 10 (extreme pain) on 3 questions; total score range 0 to 30. A decrease in the change from baseline total score in the penile pain domain of the PDQ is indicated by a negative number. Subjects were required to have a penile pain score of 4 or greater at baseline.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population; this population only includes those subjects in the mITT population with a baseline penile pain score of 4 or greater.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 114
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.3  (4.93)
5.Secondary Outcome
Title A Responder Analysis Based on Subject Overall Global Assessment
Hide Description Subject overall global assessment of Peyronie's disease score range -3 (much worse) to 3 (much improved). A score of 1 (improved in a small but important way), 2 (moderately improved), or 3 indicate a responder.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Measure Type: Number
Unit of Measure: participants
Responder Status - Yes 172
Responder Status - No 66
6.Secondary Outcome
Title Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
Hide Description Overall satisfaction domain of the IIEF score range 0 to 5 on 2 questions where higher scores indicate improved function or satisfaction; total score range 0 to 10.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (2.23)
7.Secondary Outcome
Title Change From Baseline in Penile Plaque Consistency
Hide Description Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline in penile plaque consistency is indicated by a negative number.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (0.93)
8.Secondary Outcome
Title A Composite Responder Analysis Based on Change From Baseline in Penile Curvature and in the Peyronie's Disease Bother Score
Hide Description

A composite responder is indicated by

  • a percent reduction from baseline in penile curvature greater than or equal to the threshold, and
  • a reduction from baseline in Peyronie's disease bother score greater than or equal to the threshold, or change in the overall sexual activity within the last 3 months to having vaginal intercourse from no vaginal intercourse at screening.
Time Frame Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Composite responder analysis is based on the intent-to-treat (ITT) population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 347
Measure Type: Number
Unit of Measure: participants
Responder - Yes 177
Responder - No 140
Responder - Missing 30
9.Secondary Outcome
Title Change From Baseline in Penile Length
Hide Description A negative value represents a reduction in measurement from baseline.
Time Frame Baseline and Week 36
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy is based on the mITT population.
Arm/Group Title AA4500
Hide Arm/Group Description:

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)

Overall Number of Participants Analyzed 238
Mean (Standard Deviation)
Unit of Measure: centimeters
0.4  (1.11)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500
Hide Arm/Group Description

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)

All-Cause Mortality
AA4500
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500
Affected / at Risk (%) # Events
Total   13/347 (3.75%)    
Cardiac disorders   
Acute myocardial infarction * 1  1/347 (0.29%) 
Gastrointestinal disorders   
Inguinal hernia * 1  1/347 (0.29%) 
General disorders   
Device occlusion * 1 [1]  1/347 (0.29%) 
Injury, poisoning and procedural complications   
Tendon rupture * 1  1/347 (0.29%) 
Fracture of penis * 1  1/347 (0.29%) 
Joint injury * 1  1/347 (0.29%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Prostate cancer * 1  2/347 (0.58%) 
Psychiatric disorders   
Mania * 1  1/347 (0.29%) 
Renal and urinary disorders   
Nephrolithiasis * 1  1/347 (0.29%) 
Reproductive system and breast disorders   
Penile haematoma * 1  2/347 (0.58%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism * 1  1/347 (0.29%) 
Vascular disorders   
Deep vein thrombosis * 1  1/347 (0.29%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
[1]
Right coronary artery in-stent occlusion
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500
Affected / at Risk (%) # Events
Total   297/347 (85.59%)    
General disorders   
Injection site pain * 1  93/347 (26.80%)  171
Injection site haematoma * 1  84/347 (24.21%)  139
Injection site swelling * 1  40/347 (11.53%)  68
Reproductive system and breast disorders   
Penile haematoma * 1  178/347 (51.30%)  356
Penile pain * 1  120/347 (34.58%)  261
Penile swelling * 1  91/347 (26.22%)  138
Penile haemorrhage * 1 [1]  79/347 (22.77%)  203
Penile oedema * 1  49/347 (14.12%)  120
Painful erection * 1  19/347 (5.48%)  20
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
[1]
penile ecchymosis
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.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
EMail: clinicalsite.inquiries@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01243411     History of Changes
Other Study ID Numbers: AUX-CC-802
First Submitted: November 17, 2010
First Posted: November 18, 2010
Results First Submitted: February 4, 2015
Results First Posted: April 15, 2015
Last Update Posted: October 5, 2017