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NCT04680156 · ClinicalTrials.gov registry record
Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)
A clinical trial, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- Terminated
- Registry status
- 120
- Enrollment target
NCT04680156: Clinical Trial study, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
NCT04680156 is a clinical trial that was terminated before completion, run by Endo USA Inc., a Keenova Therapeutics Company. The registered enrollment target is 120 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04680156 was terminated before completion, sponsored by Endo USA Inc., a Keenova Therapeutics Company.
- TERMINATED
- Registry status
- 120 participants
- Enrollment target
Study Summary
This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).
Primary Outcome
The change from Day 95/end of study (EOS) in the parent studies in the adapted American Shoulder and Elbow Society (ASES) composite score for the affected shoulder
Interventions
- DRUG Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-12-17 |
| Est. Completion | 2022-09-12 |
Why NCT04680156 stopped before completion
NCT04680156 is an observational study that tracks outcomes without assigning an intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies is the first listed.
NCT04680156 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04680156 about?
NCT04680156 is a clinical study titled "Long-term Follow-up Durability (Efficacy) Study of EN3835 for the Treatment of AC of the Shoulder (Frozen Shoulder)". This is a long-term follow-up study to evaluate the safety and durability (efficacy) of response to EN3835 compared to placebo in participants who were treated in EN3835-210 or the pivotal Phase 3 parent studies for the treatment of AC of the shoulder (frozen shoulder).
What is the current status of trial NCT04680156?
This trial is currently terminated. The enrollment target is 120 participants. The study started on 2020-12-17. Estimated completion is 2022-09-12.
What interventions are being tested in trial NCT04680156?
The interventions under investigation include: Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies (DRUG).
Who is sponsoring clinical trial NCT04680156?
This trial is sponsored by Endo USA Inc., a Keenova Therapeutics Company, which has 61 total clinical trials registered on ClinicalTrials.gov.
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