Trial · NCT02006719
Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
NCT02006719, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2017-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder. Trials, record NCT02006719. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02006719
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study for the Treatment of Adhesive Capsulitis of the Shoulder
- NCT number
- NCT02006719
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 322 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Interventions
- Collagenase Clostridium Histolyticum, Placebo
- First posted
- 2013-12-10
- 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 95 in Active Forward Flexion | Baseline, day 95 | Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale | Baseline, day 95 | 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 (United States adapted version). |
| Secondary | Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS) | Baseline, day 95 | Participant assessment of pain in response to "How bad is the pain upon movement of your affected shoulder at its worst in the last 24 hours?" using an 11-point NRS where 0=no pain at all and 10=pain as bad as it can be. |
| Secondary | Change From Baseline to Day 95 in Active Abduction | Baseline, day 95 | AROM measurement using a goniometer to assess abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Passive Forward Flexion | Baseline, day 95 | Passive range of motion (PROM) measurement using a goniometer to assess forward flexion in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Passive Abduction | Baseline, day 95 | PROM measurement using a goniometer to assess abduction in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Active Internal Rotation | Baseline, day 95 | AROM measurement using a goniometer to assess internal rotation in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Active External Rotation | Baseline, day 95 | AROM measurement using a goniometer to assess external rotation in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Passive Internal Rotation | Baseline, day 95 | PROM measurement using a goniometer to assess internal rotation in the affected shoulder |
| Secondary | Change From Baseline to Day 95 in Passive External Rotation | Baseline, day 95 | PROM measurement using a goniometer to assess external rotation in the affected shoulder |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 95 in Active Forward Flexion | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale | Baseline, day 95 | 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 (1 participant excluded); 34 participants missing either baseline or day 95 function subscale scores also excluded | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS) | Baseline, day 95 | 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 (1 participant excluded); 33 participants missing either baseline or day 95 pain with movement scores also excluded | units on a scale | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Active Abduction | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 active abduction measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Passive Forward Flexion | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 active forward flexion measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Passive Abduction | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 passive abduction measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Active Internal Rotation | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 active internal rotation measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Active External Rotation | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 active external rotation measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Passive Internal Rotation | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 passive internal rotation measurement also excluded | degrees | MEAN |
| SECONDARY | Change From Baseline to Day 95 in Passive External Rotation | Baseline, day 95 | 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 (1 participant excluded); 25 participants missing either baseline or day 95 passive external rotation measurement also excluded | degrees | MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline to Day 95 in Active Forward Flexion | AA4500 | 41.0 | Standard Deviation 28.89 | degrees | |
| Change From Baseline to Day 95 in Active Forward Flexion | Placebo | 35.9 | Standard Deviation 23.36 | degrees | |
| Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale | AA4500 | 17.0 | Standard Deviation 11.65 | units on a scale | |
| Change From Baseline to Day 95 in Adapted American Shoulder and Elbow Surgeons (ASES) Function Subscale | Placebo | 14.8 | Standard Deviation 11.14 | units on a scale | |
| Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS) | AA4500 | -4.4 | Standard Deviation 2.83 | units on a scale | |
| Change From Baseline to Day 95 in Pain With Movement Using 11-point Numeric Rating Scale (NRS) | Placebo | -3.9 | Standard Deviation 2.93 | units on a scale | |
| Change From Baseline to Day 95 in Active Abduction | AA4500 | 49.0 | Standard Deviation 33.10 | degrees | |
| Change From Baseline to Day 95 in Active Abduction | Placebo | 43.8 | Standard Deviation 30.71 | degrees | |
| Change From Baseline to Day 95 in Passive Forward Flexion | AA4500 | 39.3 | Standard Deviation 29.47 | degrees | |
| Change From Baseline to Day 95 in Passive Forward Flexion | Placebo | 34.1 | Standard Deviation 22.37 | degrees |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AA4500 | 237 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | COMPLETED | AA4500 | 219 | |
| Overall Study | COMPLETED | Placebo | 80 | |
| Overall Study | NOT COMPLETED | AA4500 | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events28
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 | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | AA4500 | 90 | 237 | 138 |
| other | Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Placebo | 18 | 84 | 24 |
| other | Contusion | Injury, poisoning and procedural complications | AA4500 | 71 | 237 | 106 |
| other | Contusion | Injury, poisoning and procedural complications | Placebo | 2 | 84 | 2 |
| other | Injection site bruising | General disorders | AA4500 | 52 | 237 | 65 |
| other | Injection site bruising | General disorders | Placebo | 10 | 84 | 13 |
| other | Injection site pain | General disorders | AA4500 | 50 | 237 | 77 |
| other | Injection site pain | General disorders | Placebo | 11 | 84 | 17 |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | AA4500 | 47 | 237 | 69 |
| other | Ecchymosis | Skin and subcutaneous tissue disorders | Placebo | 3 | 84 | 4 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AA4500 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | AA4500 | 188 | 237 |
| Total, other adverse events | Placebo | 37 | 84 |
| Total, serious adverse events | AA4500 | 4 | 237 |
| Total, serious adverse events | Placebo | 1 | 84 |
Source ClinicalTrials.gov
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AA4500 vs Placebo: serious adverse events |
Source Trial comparisons
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02006719
GET https://conductscience.org/api/trials/v1/NCT02006719/results?page=2