Trial · NCT01483963

AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder

NCT01483963, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2017-05-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder. Trials, record NCT01483963. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01483963

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: AA4500 for the Treatment of Adhesive Capsulitis of the Shoulder
NCT number: NCT01483963
Status: Completed
Phases: Phase 2
Enrollment: 50 participants, actual
Lead sponsor: Endo USA Inc., a Keenova Therapeutics Company
Conditions: Adhesive Capsulitis, Frozen Shoulder
Interventions: 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
First posted: 2011-12-02
Last updated: 2017-10-05
Results first posted: 2017-05-25

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline to Day 92 in Active Forward Flexion	Baseline, Day 92	Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Secondary	Change From Baseline to Day 92 in Passive Forward Flexion	Baseline, Day 92	Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Secondary	Change From Baseline to Day 92 in Active Abduction	Baseline, Day 92	AROM measurement using a goniometer to assess abduction in the affected shoulder
Secondary	Change From Baseline to Day 92 in Passive Abduction	Baseline, Day 92	PROM measurement using a goniometer to assess abduction in the affected shoulder
Secondary	Change From Baseline to Day 92 in Active External Rotation	Baseline, Day 92	AROM measurement using a goniometer to assess external rotation in the affected shoulder
Secondary	Change From Baseline to Day 92 in Passive External Rotation	Baseline, Day 92	PROM measurement using a goniometer to assess external rotation in the affected shoulder
Secondary	Change From Baseline to Day 92 in Active Internal Rotation	Baseline, Day 92	AROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Secondary	Change From Baseline to Day 92 in Passive Internal Rotation	Baseline, Day 92	PROM measurement using a goniometer to assess internal rotation with the elbow up to 90° abduction in the affected shoulder
Secondary	Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score	Baseline, Day 92	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
Secondary	Change From Baseline to Day 92 in ASES Pain Subscale	Baseline, Day 92	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

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to Day 92 in Active Forward Flexion	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Passive Forward Flexion	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Active Abduction	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Passive Abduction	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Active External Rotation	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Passive External Rotation	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Active Internal Rotation	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in Passive Internal Rotation	Baseline, Day 92	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)	degrees	MEAN
SECONDARY	Change From Baseline to Day 92 in American Shoulder and Elbow Surgeons (ASES) Composite Score	Baseline, Day 92	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)	units on a scale	MEAN
SECONDARY	Change From Baseline to Day 92 in ASES Pain Subscale	Baseline, Day 92	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)	units on a scale	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group115

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline to Day 92 in Active Forward Flexion	AA4500 0.29 mg/1 mL	22.9	Standard Deviation 13.83	degrees
Change From Baseline to Day 92 in Active Forward Flexion	AA4500 0.58 mg/2 mL	37.5	Standard Deviation 22.89	degrees
Change From Baseline to Day 92 in Active Forward Flexion	AA4500 0.58 mg/1 mL	42.9	Standard Deviation 30.64	degrees
Change From Baseline to Day 92 in Active Forward Flexion	AA4500 0.58 mg/0.5 mL	23.8	Standard Deviation 41.97	degrees
Change From Baseline to Day 92 in Active Forward Flexion	Shoulder Exercises Only	12.0	Standard Deviation 12.68	degrees
Change From Baseline to Day 92 in Passive Forward Flexion	AA4500 0.29 mg/1 mL	21.8	Standard Deviation 11.92	degrees
Change From Baseline to Day 92 in Passive Forward Flexion	AA4500 0.58 mg/2 mL	39.1	Standard Deviation 22.13	degrees
Change From Baseline to Day 92 in Passive Forward Flexion	AA4500 0.58 mg/1 mL	46.2	Standard Deviation 20.35	degrees
Change From Baseline to Day 92 in Passive Forward Flexion	AA4500 0.58 mg/0.5 mL	10.5	Standard Deviation 23.96	degrees
Change From Baseline to Day 92 in Passive Forward Flexion	Shoulder Exercises Only	12.0	Standard Deviation 14.13	degrees

1 to 10 of 115Source ClinicalTrials.gov

See all 115 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AA4500 0.29 mg/1 mL	10
Overall Study	STARTED	AA4500 0.58 mg/2 mL	10
Overall Study	STARTED	AA4500 0.58 mg/1 mL	10
Overall Study	STARTED	AA4500 0.58 mg/0.5 mL	10
Overall Study	STARTED	Shoulder Exercises Only	10
Overall Study	COMPLETED	AA4500 0.29 mg/1 mL	10
Overall Study	COMPLETED	AA4500 0.58 mg/2 mL	10
Overall Study	COMPLETED	AA4500 0.58 mg/1 mL	10
Overall Study	COMPLETED	AA4500 0.58 mg/0.5 mL	10
Overall Study	COMPLETED	Shoulder Exercises Only	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events280

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypothyroidism	Endocrine disorders	AA4500 0.29 mg/1 mL	1	10	1
other	Hypothyroidism	Endocrine disorders	AA4500 0.58 mg/2 mL	0	10	0
other	Hypothyroidism	Endocrine disorders	AA4500 0.58 mg/1 mL	0	10	0
other	Hypothyroidism	Endocrine disorders	AA4500 0.58 mg/0.5 mL	0	10	0
other	Hypothyroidism	Endocrine disorders	Shoulder Exercises Only	0	10	0
other	Conjunctival haemorrhage	Eye disorders	AA4500 0.29 mg/1 mL	0	10	0
other	Conjunctival haemorrhage	Eye disorders	AA4500 0.58 mg/2 mL	0	10	0
other	Conjunctival haemorrhage	Eye disorders	AA4500 0.58 mg/1 mL	0	10	0
other	Conjunctival haemorrhage	Eye disorders	AA4500 0.58 mg/0.5 mL	1	10	1
other	Conjunctival haemorrhage	Eye disorders	Shoulder Exercises Only	0	10	0

1 to 10 of 280Source ClinicalTrials.gov

See all 280 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AA4500 0.29 mg/1 mL	0	10
Total, all-cause mortality	AA4500 0.58 mg/2 mL	0	10
Total, all-cause mortality	AA4500 0.58 mg/1 mL	0	10
Total, all-cause mortality	AA4500 0.58 mg/0.5 mL	0	10
Total, all-cause mortality	Shoulder Exercises Only	0	10
Total, other adverse events	AA4500 0.29 mg/1 mL	9	10
Total, other adverse events	AA4500 0.58 mg/2 mL	9	10
Total, other adverse events	AA4500 0.58 mg/1 mL	10	10
Total, other adverse events	AA4500 0.58 mg/0.5 mL	10	10
Total, other adverse events	Shoulder Exercises Only	2	10

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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