Trial · NCT04496167
Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
NCT04496167, Phase 2, Completed, Endo USA Inc., a Keenova Therapeutics Company; results first posted 2023-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of EN3835 in Participants With Frozen Shoulder. Trials, record NCT04496167. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04496167
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
- NCT number
- NCT04496167
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 198 participants, actual
- Lead sponsor
- Endo USA Inc., a Keenova Therapeutics Company
- Conditions
- Adhesive Capsulitis, Frozen Shoulder
- Interventions
- EN3835, Placebo
- First posted
- 2020-08-03
- Last updated
- 2023-09-13
- Results first posted
- 2023-09-13
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 | Baseline, Day 95 | Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function). Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function. |
| Secondary | Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for forward flexion was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for internal rotation was measured using a goniometer and a spinal level. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for External Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for external rotation was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Abduction in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for abduction was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | PROM for shoulder extension was measured using a goniometer. Positive change from Baseline means an improvement. |
| Secondary | Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for forward flexion was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for internal rotation was measured using a goniometer and a spinal level. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for external rotation was measured using a goniometer PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
| Secondary | Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | PROM for abduction was measured using a goniometer. PROM measurements for the contralateral (unaffected) shoulder were taken at Baseline. PROM measurements of the affected shoulder were take at Baseline, Days 22, 43, 64, and 95. Baseline Value = Measurement at Baseline in Affected Shoulder- Measurement at Baseline Contralateral Unaffected Shoulder Change from baseline was calculated as: (Measurement at Visit in Affected Shoulder - Measurement at Baseline Contralateral Shoulder) - Baseline Value |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 | Baseline, Day 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment and had both Baseline and Day 95 measurements. Here, overall number of participants analyzed = participants evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for External Rotation in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Abduction in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Shoulder Extension in the Affected Shoulder | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Forward Flexion in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Internal Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for External Rotation in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
| SECONDARY | Change From Baseline in PROM for Abduction in the Affected Shoulder Compared to the Contralateral (Unaffected) Shoulder at Baseline | Baseline, Days 22, 43, 64, and 95 | Modified intent-to-treat population included all randomized participants who received at least 1 injection of study treatment and who had a valid baseline adapted ASES composite score in the affected shoulder and at least 1 valid adapted ASES composite score after the injection of the study treatment. Here, number analyzed = participants evaluable at specified time-point (had both Baseline and measurements at specified timepoints). | degrees | MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 | EN3835 | 41.35 | Standard Deviation 22.432 | score on a scale | |
| Change From Baseline in the Adapted American Shoulder and Elbow Surgeons Shoulder Assessment Form (ASES) Composite Score for the Affected Shoulder at Day 95 | Placebo | 41.16 | Standard Deviation 21.942 | score on a scale | |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | EN3835 | Day 22 | 19.1 | Standard Deviation 24.88 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Placebo | Day 22 | 13.9 | Standard Deviation 22.40 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | EN3835 | Day 43 | 25.6 | Standard Deviation 26.89 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Placebo | Day 43 | 21.4 | Standard Deviation 20.14 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | EN3835 | Day 64 | 31.4 | Standard Deviation 26.31 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Placebo | Day 64 | 27.3 | Standard Deviation 23.68 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | EN3835 | Day 95 | 32.8 | Standard Deviation 25.59 | degrees |
| Change From Baseline in Passive Range of Motion (PROM) for Forward Flexion in the Affected Shoulder | Placebo | Day 95 | 29.7 | Standard Deviation 27.08 | degrees |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | EN3835 | 102 | |
| Overall Study | STARTED | Placebo | 96 | |
| Overall Study | Received at Least 1 Dose of Study Drug | EN3835 | 101 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Placebo | 94 | |
| Overall Study | COMPLETED | EN3835 | 84 | |
| Overall Study | COMPLETED | Placebo | 80 | |
| Overall Study | NOT COMPLETED | EN3835 | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events12
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 | Injection site bruising | General disorders | EN3835 | 47 | 101 | |
| other | Injection site bruising | General disorders | Placebo | 4 | 94 | |
| other | Injection site pain | General disorders | EN3835 | 23 | 101 | |
| other | Injection site pain | General disorders | Placebo | 10 | 94 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | EN3835 | 23 | 101 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Placebo | 12 | 94 | |
| other | Injection site swelling | General disorders | EN3835 | 14 | 101 | |
| other | Injection site swelling | General disorders | Placebo | 2 | 94 | |
| serious | Depression | Psychiatric disorders | EN3835 | 1 | 101 | |
| serious | Depression | Psychiatric disorders | Placebo | 0 | 94 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EN3835 | 0 | 101 |
| Total, all-cause mortality | Placebo | 0 | 94 |
| Total, other adverse events | EN3835 | 69 | 101 |
| Total, other adverse events | Placebo | 22 | 94 |
| Total, serious adverse events | EN3835 | 1 | 101 |
| Total, serious adverse events | Placebo | 1 | 94 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| EN3835 vs Placebo: deaths from any cause | Trial comparisons |
| EN3835 vs Placebo: serious adverse events | 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/NCT04496167
GET https://conductscience.org/api/trials/v1/NCT04496167/registered?page=2