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NCT04094298 · ClinicalTrials.gov registry record · Phase 3
Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease
A Phase 3 study of Rotator Cuff Tears and Rotator Cuff Tendinitis, sponsored by Northwell Health.
- Active
- Registry status
- Phase 3
- Development phase
- 65
- Enrollment target
- 1
- Study location
NCT04094298: Active Phase 3 study of Rotator Cuff Tears and Rotator Cuff Tendinitis, sponsored by Northwell Health.
NCT04094298 is a Phase 3 study of Rotator Cuff Tears and Rotator Cuff Tendinitis that is active but no longer recruiting, run by Northwell Health. The registered enrollment target is 65 participants, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04094298, a Phase 3 study of Rotator Cuff Tears and Rotator Cuff Tendinitis, is active but no longer recruiting, sponsored by Northwell Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 65 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using extended release triamcinolone to treat shoulder pain from rotator cuff disease. Inclusion criteria will be shoulder pain without a history of trauma and physical exam consistent with rotator cuff tendinitis, impingement syndrome or rotator cuff tear.
Primary Outcome
Assess the overall safety extended release triamcinolone in acetate (TA-ER/FX006) in patient with rotator cuff disease. Safety is evaluated on the basis of incidence of adverse events (AE). These would be reported by the patient or discovered by the investigator from the following measure below: VAS (Visual Analogue Scale) is a scale to measure patient's pain. SANE (Single Assessment Numeric Evaluation) a scale of 0 to 100 that patients rate their joint function, with 100 being normal function.
Conditions Studied
Interventions
- DRUG FX006 Injection
Study Locations (1)
New York
- Northwell Health Orthopedic Institute at Great Neck - Great Neck
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2019-07-15 |
| Est. Completion | 2025-01-31 |
| Phase | Phase 3 |
What the registry record for NCT04094298 still lists
NCT04094298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Rotator Cuff Tears appearing as the primary indexed condition, and to 1 intervention - of which FX006 Injection is the first listed.
NCT04094298 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04094298 about?
NCT04094298 is a clinical study titled "Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease". The primary objective of this study is to assess the overall safety and general tolerability of extended release triamcinolone acetate (TA-ER/FX006) in patient with rotator cuff disease. The study will enroll 65 patients, aged 40-75 years old, in a longitudinal case series level IV study using exten...
What is the current status of trial NCT04094298?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2019-07-15. Estimated completion is 2025-01-31.
What conditions does trial NCT04094298 study?
This clinical trial studies the following conditions: Rotator Cuff Tears, Rotator Cuff Tendinitis, Rotator Cuff Impingement, Injections, Glucocorticoids.
What interventions are being tested in trial NCT04094298?
The interventions under investigation include: FX006 Injection (DRUG).
Who is sponsoring clinical trial NCT04094298?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04094298 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04094298's enrollment target sits among peer trials
65 12th of 20 higher than 9 of 20 other Rotator Cuff Tears trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rotator Cuff Tears 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.
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