RecruitingPhase 3NCT06269705

ZILRETTA in Subjects With Shoulder Osteoarthritis

A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis

Sponsor

Pacira Pharmaceuticals, Inc

Enrollment

150 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Glenohumeral Osteoarthritis

Summary

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 placebo Secondary Objective: * To assess the efficacy of ZILRETTA on pain following an IA injection in subjects with glenohumeral OA relative to triamcinolone acetonide injectable suspension, and normal saline placebo * To assess the safety of ZILRETTA in subjects with glenohumeral OA relative to normal saline placebo

Eligibility

Min Age: 50 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ZILRETTA, a long-acting steroid injection, for people with shoulder joint pain caused by osteoarthritis (wear-and-tear arthritis). Researchers want to know how well it relieves pain compared to other treatments. **You may be eligible if...** - You are between 50 and 80 years old - You have shoulder pain caused by osteoarthritis of the shoulder joint - Your body size allows the doctor to properly locate and inject into the shoulder joint **You may NOT be eligible if...** - You do not meet the inclusion criteria above - Your doctor determines you are not a suitable candidate for the injection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZILRETTA

IA injection of 32 mg ZILRETTA

OTHERPlacebo

IA injection of placebo (normal saline)

Locations(32)

Alabama Orthopaedic Center- Research

Vestavia Hills, Alabama, United States

Onyx Clinical Research

Surprise, Arizona, United States

Tucson Orthopaedic Institute (TOI) - East Office

Tucson, Arizona, United States

Horizon Clinical Research

La Mesa, California, United States

Napa Pain Institute

Napa, California, United States

Stanford University - Sports Medicine Clinic

Redwood City, California, United States

International Spine, Pain & Performance Center

Washington D.C., District of Columbia, United States

Orthopedic Center of Palm Beach City

Atlantis, Florida, United States

Baptist Health Orthopedic Care - Miami Gardens

Maimi, Florida, United States

Infinite Clinical Research

Miami, Florida, United States

Gulfcoast Research Institute

Sarasota, Florida, United States

Clinical Research of West Florida

Tampa, Florida, United States

Hospital for Special Services

West Palm Beach, Florida, United States

Injury Care Research

Boise, Idaho, United States

Kansas City Bone & Joint Clinic - Overland Park

Overland Park, Kansas, United States

Ochsner Sports Medicine Institute

New Orleans, Louisiana, United States

New England Baptist Hospital

Boston, Massachusetts, United States

Oakland Medical Center

Troy, Michigan, United States

Sundance Clinical Research

St Louis, Missouri, United States

New York-Presbyterian Queens

Flushing, New York, United States

West Clinical Research

Morehead City, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

Ohio State University

Columbus, Ohio, United States

University Orthopedics Center

Altoona, Pennsylvania, United States

Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

University Orthopedics Center (UOC) - State College

State College, Pennsylvania, United States

Medical University Health - West Ashley Medical Pavilion

Charleston, South Carolina, United States

Texas Orthopedic Specialists, PLLC

Bedford, Texas, United States

First Surgical Hospital

Bellaire, Texas, United States

El Paso Clinical Trials, LLC

El Paso, Texas, United States

Physicians Research Options

Draper, Utah, United States

Spectrum Medical

Danville, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06269705

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