ZILRETTA for Shoulder Osteoarthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
Primary Objective: To assess the efficacy of ZILRETTA on pain following an intra-articular (IA) injection in subjects with glenohumeral osteoarthritis (OA) relative to normal saline placeboSecondary Objective:* To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, immediate release (TCA-IR) and normal saline placebo* To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo and TCA-IR
Will I have to stop taking my current medications?
The trial requires participants to stop taking certain medications, such as opioids, other pain relievers, and products containing THC or CBD. If you are on these or other restricted medications, you may need to stop them before joining the study.
Is ZILRETTA safe for use in humans?
ZILRETTA, a form of triamcinolone acetonide, has been shown to be generally well tolerated in clinical trials for osteoarthritis pain in the knee, with a safety profile similar to placebo and other forms of triamcinolone acetonide. It reduces systemic exposure, which lessens the risk of side effects like blood sugar increases. Studies on shoulder osteoarthritis also evaluated its safety, indicating it is generally safe for human use.12345
How is the drug ZILRETTA different from other treatments for shoulder osteoarthritis?
ZILRETTA is unique because it uses a special microsphere technology to slowly release the medication directly into the joint, providing longer-lasting pain relief with reduced side effects compared to standard treatments. This extended-release formulation helps keep the drug in the joint longer, minimizing its presence in the rest of the body and reducing potential side effects like blood sugar spikes.12367
What data supports the effectiveness of the drug ZILRETTA for shoulder osteoarthritis?
Research shows that Triamcinolone Acetonide Extended-Release (ZILRETTA) is effective in reducing pain and improving function in knee osteoarthritis, with a similar formulation being studied for shoulder osteoarthritis. The extended-release formulation allows for prolonged presence in the joint, potentially offering longer-lasting relief compared to standard treatments.12389
Who Is on the Research Team?
Nino Joy, MD
Principal Investigator
Pacira Pharmaceuticals, Inc
Are You a Good Fit for This Trial?
This trial is for individuals with shoulder osteoarthritis, specifically in the glenohumeral joint. Participants should have a history of pain due to their condition and be suitable candidates for intra-articular injection treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Participants undergo pre-treatment assessments and training, including eDiary registration and training for accurate pain reporting
Treatment
Participants receive a single intra-articular injection of either ZILRETTA, TCA-IR, or placebo
Follow-up
Participants are monitored for safety and effectiveness with outpatient visits and daily eDiary entries
What Are the Treatments Tested in This Trial?
Interventions
- TCA-IR
- ZILRETTA
ZILRETTA is already approved in United States for the following indications:
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Who Is Running the Clinical Trial?
Pacira Pharmaceuticals, Inc
Lead Sponsor
Dr. Jonathan Slonin
Pacira Pharmaceuticals, Inc
Chief Medical Officer since 2020
BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University
Frank D. Lee
Pacira Pharmaceuticals, Inc
Chief Executive Officer since 2024
BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business