Clinical Trial

Use of Extended Release Triamcinolone in the Treatment of Rotator Cuff Disease

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 12 amendments
This ClinicalTrials.gov record has been amended 12 times since 2019-09-17; most recent amendment 2025-10-17.
Status change: Active, Not Recruiting → Completed 2025-10-17
Status change: Recruiting → Active, Not Recruiting 2024-12-24
Status change: Suspended → Recruiting 2020-07-16
Status change: Recruiting → Suspended 2020-03-03
Trial Details
NCT Number NCT04094298
Lead Sponsor Northwell Health
Conditions Rotator Cuff Tears, Rotator Cuff Tendinitis, Rotator Cuff Impingement, Injections, Glucocorticoids
Enrollment 65 participants
Start Date 2019-07-15
Primary Completion 2024-10-10 (estimated)
Study Completion 2025-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-12-27