Trial Outcomes & Findings for The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease (NCT NCT00755222)
NCT ID: NCT00755222
Last Updated: 2017-10-05
Results Overview
Negative change reflects improvement in penile curvature
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
147 participants
Primary outcome timeframe
Baseline and Week 36 or last observation carried forward (LOCF)
Results posted on
2017-10-05
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
36
|
|
Overall Study
COMPLETED
|
103
|
34
|
|
Overall Study
NOT COMPLETED
|
8
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
The Safety and Effectiveness of AA4500 in Subjects With Peyronie's Disease
Baseline characteristics by cohort
| Measure |
AA4500
n=111 Participants
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
n=36 Participants
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
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
95 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Continuous
|
56.9 years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 6.95 • n=7 Participants
|
56.6 years
STANDARD_DEVIATION 7.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
111 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
36 participants
n=7 Participants
|
147 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 36 or last observation carried forward (LOCF)Negative change reflects improvement in penile curvature
Outcome measures
| Measure |
AA4500
n=109 Participants
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
n=36 Participants
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.
|
|---|---|---|
|
Change From Baseline in Penile Curvature
|
-29.7 Percent change from baseline
Standard Deviation 27.16
|
-11.0 Percent change from baseline
Standard Deviation 30.87
|
PRIMARY outcome
Timeframe: Baseline to Week 36 or LOCFPeyronie'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.
Outcome measures
| Measure |
AA4500
n=100 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Change From Baseline in Peyronie's Disease Questionnaire (PDQ) Peyronie's Disease Symptom Bother
|
-2.6 scores on a scale
Standard Deviation 4.63
|
-0.8 scores on a scale
Standard Deviation 3.63
|
PRIMARY outcome
Timeframe: Baseline to Week 36 or LOCFPeyronie'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.
Outcome measures
| Measure |
AA4500
n=100 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Change From Baseline in PDQ Intercourse Contraint
|
-1.5 scores on a scale
Standard Deviation 3.31
|
-0.7 scores on a scale
Standard Deviation 3.65
|
PRIMARY outcome
Timeframe: Baseline to Week 36 or LOCFPeyronie'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.
Outcome measures
| Measure |
AA4500
n=100 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Change From Baseline in PDQ Intercourse Discomfort
|
-0.8 scores on a scale
Standard Deviation 3.46
|
-0.4 scores on a scale
Standard Deviation 4.27
|
PRIMARY outcome
Timeframe: Baseline to Week 36 or LOCFPeyronie'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.
Outcome measures
| Measure |
AA4500
n=100 Participants
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
n=34 Participants
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.
|
|---|---|---|
|
Change From Baseline in PDQ Penile Pain
|
-2.4 scores on a scale
Standard Deviation 6.32
|
-0.5 scores on a scale
Standard Deviation 5.30
|
Adverse Events
AA4500
Serious events: 4 serious events
Other events: 109 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AA4500
n=111 participants at risk
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
n=36 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
General disorders
Chest pain
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
Metabolism and nutrition disorders
Dehydration
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
Vascular disorders
Hypotension
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
Infections and infestations
Sepsis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/111
|
2.8%
1/36 • Number of events 1
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.90%
1/111 • Number of events 1
|
0.00%
0/36
|
Other adverse events
| Measure |
AA4500
n=111 participants at risk
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
n=36 participants at risk
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.
|
|---|---|---|
|
General disorders
Injection site bruising
|
90.1%
100/111 • Number of events 236
|
50.0%
18/36 • Number of events 36
|
|
General disorders
Injection site edema
|
49.5%
55/111 • Number of events 87
|
0.00%
0/36
|
|
General disorders
Injection site pain
|
55.0%
61/111 • Number of events 109
|
13.9%
5/36 • Number of events 7
|
|
General disorders
Injection site pruritus
|
5.4%
6/111 • Number of events 8
|
0.00%
0/36
|
|
Injury, poisoning and procedural complications
Contusion
|
22.5%
25/111 • Number of events 42
|
5.6%
2/36 • Number of events 4
|
|
Reproductive system and breast disorders
General disorder male
|
5.4%
6/111 • Number of events 7
|
5.6%
2/36 • Number of events 3
|
|
Reproductive system and breast disorders
Painful erection
|
6.3%
7/111 • Number of events 9
|
2.8%
1/36 • Number of events 1
|
|
Reproductive system and breast disorders
Penile edema
|
12.6%
14/111 • Number of events 17
|
2.8%
1/36 • Number of events 1
|
|
Reproductive system and breast disorders
Penile pain
|
12.6%
14/111 • Number of events 14
|
0.00%
0/36
|
|
Reproductive system and breast disorders
Peyronie's disease
|
0.00%
0/111
|
5.6%
2/36 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER