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Trial record 18 of 51 for:    "Frozen Shoulder"

AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01483963
Recruitment Status : Completed
First Posted : December 2, 2011
Results First Posted : May 25, 2017
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: None (Open Label);   Primary Purpose: Treatment
Conditions Adhesive Capsulitis
Frozen Shoulder
Interventions Biological: AA4500 0.29 mg/1 mL
Biological: AA4500 0.58 mg/2 mL
Biological: AA4500 0.58 mg/1 mL
Biological: AA4500 0.58 mg/0.5 mL
Other: Shoulder exercises
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Period Title: Overall Study
Started 10 10 10 10 10
Completed 10 10 10 10 10
Not Completed 0 0 0 0 0
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only Total
Hide Arm/Group Description

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Total of all reporting groups
Overall Number of Baseline Participants 10 10 10 10 10 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
49.1  (4.93) 54.1  (8.81) 58.4  (8.97) 53.2  (5.71) 55.1  (7.02) 54.0  (7.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
Female
8
  80.0%
8
  80.0%
9
  90.0%
8
  80.0%
7
  70.0%
40
  80.0%
Male
2
  20.0%
2
  20.0%
1
  10.0%
2
  20.0%
3
  30.0%
10
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
Hispanic or Latino
2
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.0%
Not Hispanic or Latino
8
  80.0%
10
 100.0%
10
 100.0%
10
 100.0%
10
 100.0%
48
  96.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.0%
Native Hawaiian or Other Pacific Islander
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
9
  90.0%
10
 100.0%
9
  90.0%
10
 100.0%
10
 100.0%
48
  96.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 10 participants 10 participants 10 participants 50 participants
10 10 10 10 10 50
1.Primary Outcome
Title Change From Baseline to Day 92 in Active Forward Flexion
Hide Description Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
22.9  (13.83) 37.5  (22.89) 42.9  (30.64) 23.8  (41.97) 12.0  (12.68)
2.Secondary Outcome
Title Change From Baseline to Day 92 in Passive Forward Flexion
Hide Description Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
21.8  (11.92) 39.1  (22.13) 46.2  (20.35) 10.5  (23.96) 12.0  (14.13)
3.Secondary Outcome
Title Change From Baseline to Day 92 in Active Abduction
Hide Description AROM measurement using a goniometer to assess abduction in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
28.4  (15.81) 36.0  (32.94) 53.7  (27.59) 35.8  (41.02) 16.7  (8.06)
4.Secondary Outcome
Title Change From Baseline to Day 92 in Passive Abduction
Hide Description PROM measurement using a goniometer to assess abduction in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
28.6  (15.69) 44.8  (34.69) 56.1  (30.05) 18.0  (40.87) 24.3  (29.69)
5.Secondary Outcome
Title Change From Baseline to Day 92 in Active External Rotation
Hide Description AROM measurement using a goniometer to assess external rotation in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
24.8  (13.39) 19.7  (27.49) 16.6  (16.79) 7.4  (29.15) 6.0  (27.87)
6.Secondary Outcome
Title Change From Baseline to Day 92 in Passive External Rotation
Hide Description PROM measurement using a goniometer to assess external rotation in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
20.0  (9.64) 19.3  (24.57) 40.9  (33.71) 9.1  (29.32) 10.7  (20.27)
7.Secondary Outcome
Title Change From Baseline to Day 92 in Active Internal Rotation
Hide Description AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
8.1  (14.12) 13.0  (20.85) 9.5  (26.87) 17.4  (24.43) 1.2  (20.92)
8.Secondary Outcome
Title Change From Baseline to Day 92 in Passive Internal Rotation
Hide Description PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: degrees
8.4  (16.87) 19.8  (21.70) 13.1  (23.38) 23.6  (18.77) 2.9  (17.55)
9.Secondary Outcome
Title Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score
Hide Description Composite score ranging from 0-100, with 0 being worst pain and function loss, derived from the sum of the scores from pain subscale (11-point NRS where 0=no pain at all and 10=pain) and function subscale (activity questionnaire where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 9 9 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
26.9  (13.17) 41.6  (18.99) 35.9  (24.33) 19.3  (24.29) 9.9  (15.84)
10.Secondary Outcome
Title Change From Baseline to Day 92 in ASES Pain Subscale
Hide Description Pain subscale score ranging from 0-50, with 0 being greatest pain, derived from participant assessment of pain in response to "How bad is the pain in your affected shoulder today?" on an 11-point numerical rating scale (NRS) where 0=no pain at all and 10=pain as bad as it can be and calculated as (10 - NRS score) x 5); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
10.0  (11.06) 15.5  (13.22) 15.5  (14.99) 8.0  (12.52) 1.5  (11.32)
11.Secondary Outcome
Title Change From Baseline to Day 92 in ASES Function Subscale
Hide Description Function subscale score ranging from 0-50, with 0 being most dysfunctional, derived from participant assessment of ability to do 10 activities with affected shoulder/arm where 0=unable to do to, 1=very difficult to do, 2=somewhat difficult, and 3=not difficult, and calculated as (cumulative total score for the 10 activity items) × (5/3); adapted from ASES Standardized Shoulder Assessment Form, Patient Self-Evaluation
Time Frame Baseline, Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 9 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
17.4  (8.72) 26.0  (10.98) 19.2  (12.36) 11.3  (13.53) 8.4  (5.85)
12.Secondary Outcome
Title Subject Satisfaction With Treatment at Day 92
Hide Description Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.
Time Frame Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Very satisfied
4
  40.0%
6
  60.0%
8
  80.0%
3
  30.0%
5
  50.0%
Quite satisfied
4
  40.0%
2
  20.0%
1
  10.0%
3
  30.0%
2
  20.0%
Neither satisfied nor dissatisfied
2
  20.0%
1
  10.0%
0
   0.0%
3
  30.0%
3
  30.0%
Quite dissatisfies
0
   0.0%
1
  10.0%
1
  10.0%
1
  10.0%
0
   0.0%
Very dissatisfied
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
13.Secondary Outcome
Title Investigator Assessment of Improvement With Treatment at Day 92
Hide Description Investigator assessment of degree of improvement in severity of the participant's treated shoulder compared with screening rated as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
Time Frame Day 92
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who have a baseline AROM measurement of the affected shoulder and at least 1 measurement of AROM of the affected shoulder following the first administration of study drug (AA4500 groups) or post baseline (shoulder exercises only group)
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description:

Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Overall Number of Participants Analyzed 10 10 10 10 10
Measure Type: Count of Participants
Unit of Measure: Participants
Very much improved
1
  10.0%
5
  50.0%
7
  70.0%
3
  30.0%
2
  20.0%
Much improved
3
  30.0%
2
  20.0%
2
  20.0%
1
  10.0%
2
  20.0%
Minimally improved
5
  50.0%
2
  20.0%
1
  10.0%
5
  50.0%
3
  30.0%
No change
1
  10.0%
0
   0.0%
0
   0.0%
1
  10.0%
2
  20.0%
Minimally worse
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
  10.0%
Much worse
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Very much worse
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Time Frame 129 days (up to 30 day screening period and 92±7 day study period)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Hide Arm/Group Description

Up to 3 injections of AA4500 0.29 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/2 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/1 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Up to 3 injections of AA4500 0.58 mg/0.5 mL

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

Home shoulder exercises for 64 days

Shoulder exercises: Home shoulder exercises, minimum of 3 times per day

All-Cause Mortality
AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AA4500 0.29 mg/1 mL AA4500 0.58 mg/2 mL AA4500 0.58 mg/1 mL AA4500 0.58 mg/0.5 mL Shoulder Exercises Only
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      9/10 (90.00%)      10/10 (100.00%)      10/10 (100.00%)      2/10 (20.00%)    
Endocrine disorders           
Hypothyroidism * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Eye disorders           
Conjunctival haemorrhage * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Gastrointestinal disorders           
Gastric ulcer * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nausea * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
General disorders           
Axillary pain * 1  0/10 (0.00%)  0 1/10 (10.00%)  2 1/10 (10.00%)  3 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site coldness * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site discomfort * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site erythema * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Injection site haematoma * 1  4/10 (40.00%)  7 4/10 (40.00%)  7 3/10 (30.00%)  4 6/10 (60.00%)  8 0/10 (0.00%)  0
Injection site haemorrhage * 1  1/10 (10.00%)  1 2/10 (20.00%)  4 3/10 (30.00%)  4 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site oedema * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Injection site pain * 1  6/10 (60.00%)  11 6/10 (60.00%)  13 6/10 (60.00%)  14 4/10 (40.00%)  6 0/10 (0.00%)  0
Injection site pruritus * 1  1/10 (10.00%)  1 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site reaction * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Injection site swelling * 1  2/10 (20.00%)  2 3/10 (30.00%)  3 2/10 (20.00%)  3 5/10 (50.00%)  6 0/10 (0.00%)  0
Oedema peripheral * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Hepatobiliary disorders           
Biliary colic * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Immune system disorders           
Hypersensitivity * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Infections and infestations           
Bronchitis * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Hordeolum * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Localised infection * 1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Nasopharyngitis * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Injury, poisoning and procedural complications           
Accident at work * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Contusion * 1  1/10 (10.00%)  1 2/10 (20.00%)  2 1/10 (10.00%)  1 1/10 (10.00%)  2 0/10 (0.00%)  0
Fall * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Joint injury * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Ligament sprain * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Procedural pain * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Investigations           
Blood glucose decreased * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Metabolism and nutrition disorders           
Diabetes mellitus * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1
Musculoskeletal and connective tissue disorders           
Arthralgia * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  2 0/10 (0.00%)  0
Joint stiffness * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Joint swelling * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Muscle tightness * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Musculoskeletal pain * 1  2/10 (20.00%)  2 1/10 (10.00%)  2 4/10 (40.00%)  7 2/10 (20.00%)  2 2/10 (20.00%)  3
Myalgia * 1  0/10 (0.00%)  0 1/10 (10.00%)  2 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Pain in extremity * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 2/10 (20.00%)  3 0/10 (0.00%)  0
Nervous system disorders           
Hypokinesia * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Migraine * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Paraesthesia * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 1/10 (10.00%)  1 0/10 (0.00%)  0
Poor quality sleep * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Psychiatric disorders           
Depression * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0
Insomnia * 1  2/10 (20.00%)  2 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Renal and urinary disorders           
Glycosuria * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Respiratory, thoracic and mediastinal disorders           
Dyspnoea * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin and subcutaneous tissue disorders           
Alopecia * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Dry skin * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Ecchymosis * 1  1/10 (10.00%)  1 1/10 (10.00%)  1 2/10 (20.00%)  2 1/10 (10.00%)  1 0/10 (0.00%)  0
Eczema * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Erythema * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Pruritus * 1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Rash * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin hyperpigmentation * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Skin ulcer * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
Urticaria * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0
Vascular disorders           
Hypertension * 1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0 0/10 (0.00%)  0
1
Term from vocabulary, MedDRA (14.0)
*
Indicates events were collected by non-systematic assessment
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
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals Inc.
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01483963     History of Changes
Other Study ID Numbers: AUX-CC-870
First Submitted: November 30, 2011
First Posted: December 2, 2011
Results First Submitted: April 18, 2017
Results First Posted: May 25, 2017
Last Update Posted: October 5, 2017