NCT04094298

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to assess the safety and efficacy of TA-ER in the treatment of rotator cuff disease. The study will enroll 65 patients 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. Patients will have normal Xrays or Xrays indicative of chronic cuff tearing and a musculoskeletal ultrasound indicating an intact rotator cuff, partial cuff tearing or cuff tear. Patients will undergo an ultrasound guided injection of TA-ER into the subacromial space from a lateral access point at the time of the examination. They will be monitored for any immediate adverse effects. Patient reported outcomes measures will be recorded with online questionnaires which include a Visual Analog Scale (VAS), Single assessment numeric evaluation (SANE), Veteran's Rand 12 (VR-12) and American Shoulder and Elbow Scale (ASES) and will be recorder pre-treatment and at 2, 4, 8 and 12 and 24 weeks post treatment. Patients will be asked to follow up for an in person evaluation at 4 weeks, 12 weeks and 24 weeks post injection.

Conditions

• Rotator Cuff Tears
• Rotator Cuff Tendinitis
• Rotator Cuff Impingement
• Injections
• Glucocorticoids

Interventions

Type	Name	Description
DRUG	FX006 Injection	One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.

Timeline

• Start date: 2019-07-15
• Primary completion: 2024-10-10
• Completion: 2025-01-31
• First posted: 2019-09-18
• Last updated: 2024-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study