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NCT04496167 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of EN3835 in Participants With Frozen Shoulder
A Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 198
- Enrollment target
NCT04496167: Completed Phase 2 study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT04496167 is a Phase 2 study that has completed, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 198 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04496167, a Phase 2 study, has completed, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 198 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive capsulitis of the shoulder (frozen shoulder).
Primary Outcome
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) t
Interventions
- DRUG Placebo
- DRUG EN3835
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2020-07-29 |
| Est. Completion | 2022-04-14 |
| Phase | Phase 2 |
What the finished NCT04496167 record still lists
NCT04496167 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04496167 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04496167 about?
NCT04496167 is a clinical study titled "Safety and Efficacy of EN3835 in Participants With Frozen Shoulder". This study will evaluate the safety and efficacy of EN3835 for the treatment of adhesive capsulitis of the shoulder (frozen shoulder).
What is the current status of trial NCT04496167?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. The study started on 2020-07-29. Estimated completion is 2022-04-14.
What interventions are being tested in trial NCT04496167?
The interventions under investigation include: Placebo (DRUG), EN3835 (DRUG).
Who is sponsoring clinical trial NCT04496167?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04496167's enrollment target sits among peer trials
198 349th of 2000 higher than 1,652 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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