Trial Outcomes & Findings for Study of AA4500 in the Treatment of Peyronie's Disease (NCT NCT01221597)
NCT ID: NCT01221597
Last Updated: 2017-10-05
Results Overview
A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
418 participants
Primary outcome timeframe
Baseline and Week 52
Results posted on
2017-10-05
Participant Flow
Includes all subjects who were randomized and received at least 1 dose of study drug; subjects who were randomized but not treated were excluded from the population
Participant milestones
| Measure |
AA4500
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
277
|
140
|
|
Overall Study
COMPLETED
|
241
|
124
|
|
Overall Study
NOT COMPLETED
|
36
|
16
|
Reasons for withdrawal
| Measure |
AA4500
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
1
|
|
Overall Study
Withdrawal by Subject
|
20
|
6
|
|
Overall Study
Lost to Follow-up
|
6
|
5
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Other
|
3
|
4
|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
Study of AA4500 in the Treatment of Peyronie's Disease
Baseline characteristics by cohort
| Measure |
AA4500
n=277 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=140 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Total
n=417 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
|
226 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
334 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
51 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 8.94 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 8.46 • 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
|
277 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
223 participants
n=5 Participants
|
113 participants
n=7 Participants
|
336 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
54 participants
n=5 Participants
|
27 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Efficacy is based on the modified intent-to-treat population (mITT).
A negative value in the percentage change from baseline in penile curvature deformity (angle measured in degrees) indicates less curvature.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Percentage Change From Baseline in Penile Curvature
|
-37.6 percentage of curvature change
Standard Deviation 30.29
|
-21.3 percentage of curvature change
Standard Deviation 29.89
|
PRIMARY outcome
Timeframe: Baseline and Week 52Population: Efficacy is based on the mITT population.
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.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change From Baseline in the Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
|
-3.3 units on a scale
Standard Deviation 3.83
|
-2.0 units on a scale
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Week 52Population: Efficacy analysis was based on the mITT population.
A responder was defined as a subject who recorded his Peyronie's disease had either improved in a small but important way, moderately improved, or much improved in overall global assessment question.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease
Responder Status-Missing
|
1 Number of particpants
|
1 Number of particpants
|
|
A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease
Responder Status-No
|
67 Number of particpants
|
73 Number of particpants
|
|
A Responder Analysis Based on Subject Overall Global Assessment of Peyronie's Disease
Responder Status-Yes
|
131 Number of particpants
|
30 Number of particpants
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy analysis is based on the mITT population.
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.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change From Baseline in the Severity of Peyronie's Disease Physical and Psychological Symptoms
|
-3.2 units on a scale
Standard Deviation 5.23
|
-1.6 units on a scale
Standard Deviation 4.50
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy analysis is based on the mITT population.
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.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change in the Overall Satisfaction Domain of the International Index of Erectile Function (IIEF)
|
1.0 units on a scale
Standard Deviation 2.55
|
0.5 units on a scale
Standard Deviation 2.42
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy analysis is based on the mITT population.
Penile plaque consistency score range 1 (non-palpable) to 5 (hard). A decrease in the change from baseline score in penile plaque consistency is indicated by a negative number.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change From Baseline in Penile Plaque Consistency
|
-0.7 units on a scale
Standard Deviation 0.97
|
-0.6 units on a scale
Standard Deviation 0.84
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy analysis is based on the mITT population.
A negative value represents a reduction in measurement from baseline.
Outcome measures
| Measure |
AA4500
n=199 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=104 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change From Baseline in Penile Length
|
0.4 centimeters
Standard Deviation 1.29
|
0.1 centimeters
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: Efficacy analysis 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.
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.
Outcome measures
| Measure |
AA4500
n=77 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=40 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Change From Baseline in the Penile Pain Domain of the PDQ in Subjects With Baseline Penile Pain Score ≥4
|
-5.1 units on a scale
Standard Deviation 5.16
|
-4.0 units on a scale
Standard Deviation 4.09
|
SECONDARY outcome
Timeframe: Week 52Population: Efficacy analysis is based on the mITT population.
A responder was defined as a subject who satisfied the following 2 criteria at that visit: a) percent reduction from baseline in curvature deformity was ≥20% and b) reduction from baseline in PDQ Peyronie's disease bother score was ≥1, or had a change from reporting no sexual activity at screening to reporting sexual activity.
Outcome measures
| Measure |
AA4500
n=277 Participants
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=140 Participants
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score
Responder Status No
|
129 Number of participants
|
97 Number of participants
|
|
Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score
Responder Status yes
|
132 Number of participants
|
33 Number of participants
|
|
Composite Responder Based on Change in Curvature Deformity and Change in Peyronie's Disease Bother Score
Responder- Missing
|
16 Number of participants
|
10 Number of participants
|
Adverse Events
AA4500
Serious events: 27 serious events
Other events: 248 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 55 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AA4500
n=277 participants at risk
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=140 participants at risk
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Blood and lymphatic system disorders
Anaemia
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Gastrointestinal disorders
Intestinal performation
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.72%
2/277 • Number of events 2 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Vascular disorders
Orthostatic hypotension
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B cell lymphoma
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Cardiac disorders
Atrial fibrillation
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Nervous system disorders
Sciatica
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Infections and infestations
Appendicitis
|
0.00%
0/277 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/277 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ penis
|
0.00%
0/277 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/277 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/277 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.72%
2/277 • Number of events 2 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.1%
3/277 • Number of events 3 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Fracture of penis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Gastrointestinal disorders
Mesenteric artery stenosis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Reproductive system and breast disorders
Penile hematoma
|
0.72%
2/277 • Number of events 2 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
General disorders
Drug withdrawal syndrome
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Nervous system disorders
Grand mal convulsion
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Post laminectomy syndrome
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
General disorders
Chest pain
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Hepatobiliary disorders
Cholecystitis
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Nervous system disorders
Transient ischemic attack
|
0.36%
1/277 • Number of events 1 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
Other adverse events
| Measure |
AA4500
n=277 participants at risk
collagenase clostridium histolyticum
AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
Placebo
n=140 participants at risk
Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
|
|---|---|---|
|
Reproductive system and breast disorders
Penile haematoma
|
61.7%
171/277 • Number of events 394 • Throughout the study
|
13.6%
19/140 • Number of events 31 • Throughout the study
|
|
Reproductive system and breast disorders
Penile pain
|
43.0%
119/277 • Number of events 244 • Throughout the study
|
7.9%
11/140 • Number of events 15 • Throughout the study
|
|
Reproductive system and breast disorders
Penile swelling
|
41.2%
114/277 • Number of events 219 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
General disorders
Injection site pain
|
25.3%
70/277 • Number of events 127 • Throughout the study
|
3.6%
5/140 • Number of events 12 • Throughout the study
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
21.7%
60/277 • Number of events 181 • Throughout the study
|
10.0%
14/140 • Number of events 19 • Throughout the study
|
|
General disorders
injection site haematoma
|
16.2%
45/277 • Number of events 66 • Throughout the study
|
10.0%
14/140 • Number of events 18 • Throughout the study
|
|
Reproductive system and breast disorders
Penile oedema
|
16.2%
45/277 • Number of events 98 • Throughout the study
|
0.71%
1/140 • Number of events 1 • Throughout the study
|
|
General disorders
Injection site swelling
|
10.8%
30/277 • Number of events 47 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Injury, poisoning and procedural complications
Contusion
|
10.1%
28/277 • Number of events 40 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
9.4%
26/277 • Number of events 39 • Throughout the study
|
0.00%
0/140 • Throughout the study
|
|
General disorders
Injection site haemorrhage
|
5.4%
15/277 • Number of events 24 • Throughout the study
|
7.1%
10/140 • Number of events 16 • Throughout the study
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
9/277 • Number of events 9 • Throughout the study
|
5.0%
7/140 • Number of events 7 • Throughout the study
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER