Actively Recruiting
ZILRETTA in Subjects With Shoulder Osteoarthritis
Led by Pacira Pharmaceuticals, Inc · Updated on 2025-11-03
150
Participants Needed
32
Research Sites
129 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
ZILRETTA in Subjects With Shoulder Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent obtained before any study procedures
- Able and willing to follow study procedures and complete daily electronic diary questionnaires
- Aged between 50 and 80 years inclusive on the day of consent
- Body mass index (BMI) that allows proper shoulder joint injection as judged by the doctor
- Shoulder pain with glenohumeral arthritis, with or without mild rotator cuff issues; must not have positive Neer or Hawkins-Kennedy tests
- Grade 1, 2, or 3 osteoarthritis in the shoulder joint confirmed by X-ray within 6 months
- Average daily shoulder pain score between 4.0 and 9.0 on a 0-10 scale for at least 4 of the 7 days before treatment
- Average Shoulder Pain and Disability Index pain score between 4.0 and 9.0 during screening and pretreatment
- Willing to avoid certain restricted medications and therapies during the study
- Sexually active participants of childbearing potential agree to use effective contraception during the study
You will not qualify if you...
- Unable to stop prohibited or restricted medications such as opioids or cannabis products
- Symptomatic arthritis or pain in other shoulder joints or the non-affected shoulder
- Subchondral bone fractures or humeral head necrosis in the affected shoulder
- Prior fractures or significant shoulder injuries within specified time frames
- Frozen shoulder diagnosis within the past year and unresolved
- Prior shoulder surgery within the past 3 years or retained hardware
- Major shoulder abnormalities, infections, or specific systemic joint diseases
- Chronic joint, muscle, or nerve pain conditions affecting the shoulder
- High pain catastrophizing score at screening
- Known allergies to triamcinolone or PLGA
- Positive tests for HIV, hepatitis B or C
- Likely need for systemic corticosteroids during the study
- History of certain infections, malignancies, or immune system disorders
- Use of specific medications or therapies within defined time frames before screening
- Pregnant or nursing women, or men with partners planning pregnancy within 12 months
- Active substance abuse or recent use of live or certain vaccinations
- Any other medical conditions that could affect safety or study participation
- Involvement in the study as staff or relatives of staff directly conducting the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 32 locations
1
Alabama Orthopaedic Center- Research
Vestavia Hills, Alabama, United States, 35243
Actively Recruiting
2
Onyx Clinical Research
Surprise, Arizona, United States, 85374
Actively Recruiting
3
Tucson Orthopaedic Institute (TOI) - East Office
Tucson, Arizona, United States, 85712
Actively Recruiting
4
Horizon Clinical Research
La Mesa, California, United States, 91942
Actively Recruiting
5
Napa Pain Institute
Napa, California, United States, 94558
Actively Recruiting
6
Stanford University - Sports Medicine Clinic
Redwood City, California, United States, 94063
Actively Recruiting
7
International Spine, Pain & Performance Center
Washington D.C., District of Columbia, United States, 20006
Actively Recruiting
8
Orthopedic Center of Palm Beach City
Atlantis, Florida, United States, 33462
Completed
9
Baptist Health Orthopedic Care - Miami Gardens
Maimi, Florida, United States, 33056
Actively Recruiting
10
Infinite Clinical Research
Miami, Florida, United States, 33133
Actively Recruiting
11
Gulfcoast Research Institute
Sarasota, Florida, United States, 34232-6028
Actively Recruiting
12
Clinical Research of West Florida
Tampa, Florida, United States, 33606
Active, Not Recruiting
13
Hospital for Special Services
West Palm Beach, Florida, United States, 33401
Actively Recruiting
14
Injury Care Research
Boise, Idaho, United States, 83713
Actively Recruiting
15
Kansas City Bone & Joint Clinic - Overland Park
Overland Park, Kansas, United States, 66211
Actively Recruiting
16
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
Actively Recruiting
17
New England Baptist Hospital
Boston, Massachusetts, United States, 02120-2847
Actively Recruiting
18
Oakland Medical Center
Troy, Michigan, United States, 48085-5524
Actively Recruiting
19
Sundance Clinical Research
St Louis, Missouri, United States, 63141
Actively Recruiting
20
New York-Presbyterian Queens
Flushing, New York, United States, 11355-5045
Actively Recruiting
21
West Clinical Research
Morehead City, North Carolina, United States, 28557
Actively Recruiting
22
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0212
Actively Recruiting
23
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
24
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602
Actively Recruiting
25
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16653
Actively Recruiting
26
University Orthopedics Center (UOC) - State College
State College, Pennsylvania, United States, 16801
Actively Recruiting
27
Medical University Health - West Ashley Medical Pavilion
Charleston, South Carolina, United States, 29407
Actively Recruiting
28
Texas Orthopedic Specialists, PLLC
Bedford, Texas, United States, 76021
Actively Recruiting
29
First Surgical Hospital
Bellaire, Texas, United States, 77401
Actively Recruiting
30
El Paso Clinical Trials, LLC
El Paso, Texas, United States, 79935-3013
Actively Recruiting
31
Physicians Research Options
Draper, Utah, United States, 84020
Completed
32
Spectrum Medical
Danville, Virginia, United States, 24541
Actively Recruiting
Research Team
J
Jack Castaneda
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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