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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

July 15, 2019

Primary Completion Date

October 10, 2024

Study Completion Date

January 31, 2025

Conditions
Rotator Cuff TearsRotator Cuff TendinitisRotator Cuff ImpingementInjectionsGlucocorticoids
Interventions
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.

Trial Locations (1)

11021

Northwell Health Orthopedic Institute at Great Neck, Great Neck

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER