Trial Outcomes & Findings for AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder (NCT NCT01483963)

NCT ID: NCT01483963

Last Updated: 2017-10-05

Results Overview

Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline, Day 92
• Results posted on: 2017-10-05

Participant Flow

Participant milestones

Measure	AA4500 0.29 mg/1 mL 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	AA4500 0.58 mg/2 mL Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Overall Study STARTED	10	10	10	10	10
Overall Study COMPLETED	10	10	10	10	10
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

Baseline characteristics by cohort

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Total n=50 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 4.93 • n=5 Participants	54.1 years STANDARD_DEVIATION 8.81 • n=7 Participants	58.4 years STANDARD_DEVIATION 8.97 • n=5 Participants	53.2 years STANDARD_DEVIATION 5.71 • n=4 Participants	55.1 years STANDARD_DEVIATION 7.02 • n=21 Participants	54.0 years STANDARD_DEVIATION 7.60 • n=10 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	9 Participants n=5 Participants	8 Participants n=4 Participants	7 Participants n=21 Participants	40 Participants n=10 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	48 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	10 Participants n=4 Participants	10 Participants n=21 Participants	48 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	10 participants n=21 Participants	50 participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline, Day 92

Population: 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)

Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Active Forward Flexion	22.9 degrees Standard Deviation 13.83	37.5 degrees Standard Deviation 22.89	42.9 degrees Standard Deviation 30.64	23.8 degrees Standard Deviation 41.97	12.0 degrees Standard Deviation 12.68

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Passive Forward Flexion	21.8 degrees Standard Deviation 11.92	39.1 degrees Standard Deviation 22.13	46.2 degrees Standard Deviation 20.35	10.5 degrees Standard Deviation 23.96	12.0 degrees Standard Deviation 14.13

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

AROM measurement using a goniometer to assess abduction in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Active Abduction	28.4 degrees Standard Deviation 15.81	36.0 degrees Standard Deviation 32.94	53.7 degrees Standard Deviation 27.59	35.8 degrees Standard Deviation 41.02	16.7 degrees Standard Deviation 8.06

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

PROM measurement using a goniometer to assess abduction in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Passive Abduction	28.6 degrees Standard Deviation 15.69	44.8 degrees Standard Deviation 34.69	56.1 degrees Standard Deviation 30.05	18.0 degrees Standard Deviation 40.87	24.3 degrees Standard Deviation 29.69

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

AROM measurement using a goniometer to assess external rotation in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Active External Rotation	24.8 degrees Standard Deviation 13.39	19.7 degrees Standard Deviation 27.49	16.6 degrees Standard Deviation 16.79	7.4 degrees Standard Deviation 29.15	6.0 degrees Standard Deviation 27.87

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

PROM measurement using a goniometer to assess external rotation in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Passive External Rotation	20.0 degrees Standard Deviation 9.64	19.3 degrees Standard Deviation 24.57	40.9 degrees Standard Deviation 33.71	9.1 degrees Standard Deviation 29.32	10.7 degrees Standard Deviation 20.27

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Active Internal Rotation	8.1 degrees Standard Deviation 14.12	13.0 degrees Standard Deviation 20.85	9.5 degrees Standard Deviation 26.87	17.4 degrees Standard Deviation 24.43	1.2 degrees Standard Deviation 20.92

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in Passive Internal Rotation	8.4 degrees Standard Deviation 16.87	19.8 degrees Standard Deviation 21.70	13.1 degrees Standard Deviation 23.38	23.6 degrees Standard Deviation 18.77	2.9 degrees Standard Deviation 17.55

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

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

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=9 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=9 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score	26.9 units on a scale Standard Deviation 13.17	41.6 units on a scale Standard Deviation 18.99	35.9 units on a scale Standard Deviation 24.33	19.3 units on a scale Standard Deviation 24.29	9.9 units on a scale Standard Deviation 15.84

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

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

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in ASES Pain Subscale	10.0 units on a scale Standard Deviation 11.06	15.5 units on a scale Standard Deviation 13.22	15.5 units on a scale Standard Deviation 14.99	8.0 units on a scale Standard Deviation 12.52	1.5 units on a scale Standard Deviation 11.32

SECONDARY outcome

Timeframe: Baseline, Day 92

Population: 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)

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

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=9 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=9 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Change From Baseline to Day 92 in ASES Function Subscale	17.4 units on a scale Standard Deviation 8.72	26.0 units on a scale Standard Deviation 10.98	19.2 units on a scale Standard Deviation 12.36	11.3 units on a scale Standard Deviation 13.53	8.4 units on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Day 92

Population: 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)

Participant assessment of satisfaction with treatment rated as very satisfied, quite satisfied, neither satisfied nor dissatisfied, quite dissatisfied, or very dissatisfied.

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Subject Satisfaction With Treatment at Day 92 Neither satisfied nor dissatisfied	2 Participants	1 Participants	0 Participants	3 Participants	3 Participants
Subject Satisfaction With Treatment at Day 92 Quite dissatisfies	0 Participants	1 Participants	1 Participants	1 Participants	0 Participants
Subject Satisfaction With Treatment at Day 92 Very dissatisfied	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Subject Satisfaction With Treatment at Day 92 Very satisfied	4 Participants	6 Participants	8 Participants	3 Participants	5 Participants
Subject Satisfaction With Treatment at Day 92 Quite satisfied	4 Participants	2 Participants	1 Participants	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Day 92

Population: 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)

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.

Outcome measures

Measure	AA4500 0.29 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 Participants Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 Participants Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Investigator Assessment of Improvement With Treatment at Day 92 Very much improved	1 Participants	5 Participants	7 Participants	3 Participants	2 Participants
Investigator Assessment of Improvement With Treatment at Day 92 Much improved	3 Participants	2 Participants	2 Participants	1 Participants	2 Participants
Investigator Assessment of Improvement With Treatment at Day 92 Minimally improved	5 Participants	2 Participants	1 Participants	5 Participants	3 Participants
Investigator Assessment of Improvement With Treatment at Day 92 No change	1 Participants	0 Participants	0 Participants	1 Participants	2 Participants
Investigator Assessment of Improvement With Treatment at Day 92 Minimally worse	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants
Investigator Assessment of Improvement With Treatment at Day 92 Much worse	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Investigator Assessment of Improvement With Treatment at Day 92 Very much worse	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

AA4500 0.29 mg/1 mL

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

AA4500 0.58 mg/2 mL

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

AA4500 0.58 mg/1 mL

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

AA4500 0.58 mg/0.5 mL

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Shoulder Exercises Only

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AA4500 0.29 mg/1 mL n=10 participants at risk Up to 3 injections of AA4500 0.29 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/2 mL n=10 participants at risk Up to 3 injections of AA4500 0.58 mg/2 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/1 mL n=10 participants at risk Up to 3 injections of AA4500 0.58 mg/1 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	AA4500 0.58 mg/0.5 mL n=10 participants at risk Up to 3 injections of AA4500 0.58 mg/0.5 mL Shoulder exercises: Home shoulder exercises, minimum of 3 times per day	Shoulder Exercises Only n=10 participants at risk Home shoulder exercises for 64 days Shoulder exercises: Home shoulder exercises, minimum of 3 times per day
Endocrine disorders Hypothyroidism	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Eye disorders Conjunctival haemorrhage	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Gastrointestinal disorders Gastric ulcer	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Gastrointestinal disorders Nausea	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Axillary pain	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 3 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site coldness	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site discomfort	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site erythema	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site haematoma	40.0% 4/10 • Number of events 7 • 129 days (up to 30 day screening period and 92±7 day study period)	40.0% 4/10 • Number of events 7 • 129 days (up to 30 day screening period and 92±7 day study period)	30.0% 3/10 • Number of events 4 • 129 days (up to 30 day screening period and 92±7 day study period)	60.0% 6/10 • Number of events 8 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site haemorrhage	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 4 • 129 days (up to 30 day screening period and 92±7 day study period)	30.0% 3/10 • Number of events 4 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site oedema	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site pain	60.0% 6/10 • Number of events 11 • 129 days (up to 30 day screening period and 92±7 day study period)	60.0% 6/10 • Number of events 13 • 129 days (up to 30 day screening period and 92±7 day study period)	60.0% 6/10 • Number of events 14 • 129 days (up to 30 day screening period and 92±7 day study period)	40.0% 4/10 • Number of events 6 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site pruritus	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site reaction	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Injection site swelling	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	30.0% 3/10 • Number of events 3 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 3 • 129 days (up to 30 day screening period and 92±7 day study period)	50.0% 5/10 • Number of events 6 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
General disorders Oedema peripheral	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Hepatobiliary disorders Biliary colic	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Immune system disorders Hypersensitivity	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Infections and infestations Bronchitis	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Infections and infestations Hordeolum	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Infections and infestations Localised infection	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Infections and infestations Nasopharyngitis	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Accident at work	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Contusion	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Fall	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Joint injury	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Injury, poisoning and procedural complications Procedural pain	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Investigations Blood glucose decreased	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Joint stiffness	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Joint swelling	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	40.0% 4/10 • Number of events 7 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 3 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 3 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Nervous system disorders Hypokinesia	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Nervous system disorders Migraine	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Nervous system disorders Paraesthesia	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Nervous system disorders Poor quality sleep	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Psychiatric disorders Depression	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Psychiatric disorders Insomnia	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Renal and urinary disorders Glycosuria	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Ecchymosis	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	20.0% 2/10 • Number of events 2 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Eczema	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Rash	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Skin hyperpigmentation	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Skin ulcer	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)
Vascular disorders Hypertension	10.0% 1/10 • Number of events 1 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)	0.00% 0/10 • 129 days (up to 30 day screening period and 92±7 day study period)

Additional Information

Clinical Trial Coordinator

Endo Pharmaceuticals Inc.

Email: clinicalsite.inquiries@endo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place