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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
Enrollment 147

Recruitment Details  
Pre-assignment Details  
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 111 36
Completed 103 34
Not Completed 8 2
Reason Not Completed
Withdrawal by Subject             4             2
Adverse Event             2             0
Protocol Violation             2             0
Arm/Group Title AA4500 Placebo Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 111 36 147
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 36 participants 147 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, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 111 participants 36 participants 147 participants
56.9  (7.79) 55.4  (6.95) 56.6  (7.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 111 participants 36 participants 147 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
111
 100.0%
36
 100.0%
147
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 111 participants 36 participants 147 participants
111 36 147
1.Primary Outcome
Title Change From Baseline in Penile Curvature
Hide Description Negative change reflects improvement in penile curvature
Time Frame Baseline and Week 36 or last observation carried forward (LOCF)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 109 36
Mean (Standard Deviation)
Unit of Measure: Percent change from baseline
-29.7  (27.16) -11.0  (30.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie’s Disease Symptom Bother
Hide Description

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.

Time Frame Baseline to Week 36 or LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 100 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.6  (4.63) -0.8  (3.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Change From Baseline in PDQ Intercourse Contraint
Hide Description

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.

Time Frame Baseline to Week 36 or LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 100 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.5  (3.31) -0.7  (3.65)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Change From Baseline in PDQ Intercourse Discomfort
Hide Description

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.

Time Frame Baseline to Week 36 or LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 100 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-0.8  (3.46) -0.4  (4.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.442
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Change From Baseline in PDQ Penile Pain
Hide Description 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.
Time Frame Baseline to Week 36 or LOCF
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 100 34
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-2.4  (6.32) -0.5  (5.30)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AA4500, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.095
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500 Placebo
Hide Arm/Group Description 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 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.
All-Cause Mortality
AA4500 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/111 (3.60%)      1/36 (2.78%)    
General disorders     
Chest pain * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
Infections and infestations     
Sepsis * 2  1/111 (0.90%)  1 0/36 (0.00%)  0
Injury, poisoning and procedural complications     
Road traffic accident * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
Neck pain * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
Osteoarthritis * 1  0/111 (0.00%)  0 1/36 (2.78%)  1
Vascular disorders     
Hypotension * 1  1/111 (0.90%)  1 0/36 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
2
Term from vocabulary, MedDRA (11.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   109/111 (98.20%)      28/36 (77.78%)    
General disorders     
Injection site bruising * 1  100/111 (90.09%)  236 18/36 (50.00%)  36
Injection site edema * 1  55/111 (49.55%)  87 0/36 (0.00%)  0
Injection site pain * 1  61/111 (54.95%)  109 5/36 (13.89%)  7
Injection site pruritus * 1  6/111 (5.41%)  8 0/36 (0.00%)  0
Injury, poisoning and procedural complications     
Contusion * 1  25/111 (22.52%)  42 2/36 (5.56%)  4
Reproductive system and breast disorders     
General disorder male * 1  6/111 (5.41%)  7 2/36 (5.56%)  3
Painful erection * 1  7/111 (6.31%)  9 1/36 (2.78%)  1
Penile edema * 1  14/111 (12.61%)  17 1/36 (2.78%)  1
Penile pain * 1  14/111 (12.61%)  14 0/36 (0.00%)  0
Peyronie's disease * 1  0/111 (0.00%)  0 2/36 (5.56%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not preceed the primary publication of the entire clinical trial.

Results Point of Contact
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals, Inc.
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