A Phase 3, Multicenter, Randomized, Double-blind, Single-dose Study to Evaluate the Efficacy and Safety of ZILRETTA in Participants with Glenohumeral Osteoarthritis.

Date Added
September 10th, 2024
PRO Number
Pro00134950
Researcher
Josef Eichinger

List of Studies


Keywords
Arthritis, Bone, Drug Studies, Pain
Summary

The purpose of this study is to evaluate the safety and efficacy of the study drug ZILRETTA (Triamcinolone Acetonide, extended release) compared to a placebo (saline solution). The study drug is administered through an ultrasound-guided injection to the affected shoulder. 66.6 percent of participants will receive Zilretta and 33 percent will receive placebo.
The study Drug ZILRETTA, is currently FDA-approved for knee osteoarthritis and is being investigated in this study for treatment of shoulder osteoarthritis. The study population consists of adults 50-80 years of age who have been diagnosed with Osteoarthritis of the shoulder by x-ray. The study has 9 study visits over 24-week's and will include, but is not limited to a questionnaire, medical examination, shoulder x-ray and blood draws. Each visit should last less than 1 hour, depending on the procedures performed. The most common side effects of the study drug are joint pain, headaches, upper respiratory infections, back pain, joint swelling, and cold symptoms.

Institution
MUSC
Recruitment Contact
Robert Reis
8437925025
reisb@musc.edu



-- OR --