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

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Dec 1, 2024 to Oct 10, 2024 · Completion date: Dec 1, 2024 to Jan 31, 2025 · Site details revisedv12 Show 3 more changesShow less
    • Primary completion date changed from estimate of Dec 1, 2024 to Oct 10, 2024
    • Completion date: Dec 1, 2024 to Jan 31, 2025
    • Site details revised
  2. Re-verified, no change to tracked fieldsv11
  3. Primary completion date: Dec 1, 2023 to Dec 1, 2024v10
  4. Primary completion date: Sep 1, 2023 to Dec 1, 2023 Completion date: Sep 1, 2024 to Dec 1, 2024v9 Show 1 more changeShow less
    • Completion date: Sep 1, 2024 to Dec 1, 2024
  5. Site contact updatedv8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Sep 1, 2021 to Sep 1, 2023 Completion date: Sep 1, 2022 to Sep 1, 2024 · Collaborators shortened, about 3 wordsv7 Show 2 more changesShow less
    • Completion date: Sep 1, 2022 to Sep 1, 2024
    • Collaborators shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  2. Re-verified, no change to tracked fieldsv6
  3. Trial status: Suspended to Recruiting Site details revisedv5 Show 1 more changeShow less
    • Site details revised
  4. Study site revised Collaborator revisedv4 Show 1 more changeShow less
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  5. Trial status: Recruiting to Suspended Sponsor's reason: Institutional roadblocks. Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  6. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov