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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04094298
The ClinicalTrials.gov registry entry for NCT04094298 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,278-participant average among 20 other Rotator Cuff Tears trials with a reported enrollment target (95% lower). The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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