Pacira Pharmaceuticals, Inc
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, 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
Glenohumeral Osteoarthritis
ZILRETTA
TCA-IR
Placebo
PHASE3
This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety of ZILRETTA in subjects with glenohumeral OA. This study will be conducted at approximately 25 study sites in the United States. Subjects will be screened to confirm the diagnosis of OA and eligibility based on the Inclusion and Exclusion Criteria. Approximately 250 male or female subjects, 50 to 80 years of age inclusive, will be enrolled, randomized to 1 of 3 treatment groups (2:2:1), and treated with a single IA injection of either: * Treatment Arm 1: 32 mg ZILRETTA, * Treatment Arm 2: 40 mg Immediate Release Triamcinolone (TCA-IR), or * Treatment Arm 3: placebo (normal saline). ZILRETTA, TCA-IR, or normal saline placebo will be administered as a single IA injection with a 24-week follow-up period with a primary endpoint at Week 12. The study will involve a Screening period (a minimum of 10 days, up to a maximum of 35 days), pre-treatment phase, dosing at Baseline/Day 1, and 8 additional outpatient visits at Weeks 2, 4, 8, 12, 16, 18, 20, and 24/End of Study (EOS) during the study. At specified times throughout the study, subjects will undergo physical examinations, index shoulder assessments, and index shoulder X-rays; blood will be collected for laboratory safety tests; and vital signs will be collected. Information regarding adverse events (AEs) and prior and concomitant medications and treatments will be collected from the time of signing the Informed Consent Form (ICF) through the Week 24/EOS visit. Information regarding rescue medication usage, Average and Worst daily Pain score (0-10 Numeric Rating Scale (NRS); 0 = no pain, 10 = worst possible pain) in the index shoulder, and Sleep Interference (SI) will be completed daily via an electronic diary (eDiary) and reviewed for compliance by site staff at each study visit. At the Screening Visit, subjects will be registered in the eDiary and receive instructions on its use. Subjects will complete accurate pain reporting (APR) and placebo response reduction (PRR) training prior to completing all questionnaires.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 250 participants |
Masking : | SINGLE |
Masking Description : | Only unblinded team (pharmacist, unblinded coordinator, drug administrator) will know the treatment assignment. A site-specific blinding plan will be developed to ensure blinding. Unblinded team will only interact with the subject at treatment and will not have any blinded roles on the study (only exception- informed consent). The subject and the assessor responsible for assessments/safety monitoring will be blinded. Site and Sponsor personnel/representatives will be blinded, with the following Sponsor/representative exceptions: unblinded monitors for performing drug accountability, unblinded clinical manager for reviewing unblinded monitoring visit reports and escalation of site unblinded issues, inventory manager for addressing product-related issues, and regulatory personnel for safety reporting. Information regarding treatment assignments will be kept securely at Sponsor. |
Primary Purpose : | TREATMENT |
Official Title : | A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis |
Actual Study Start Date : | 2024-02-05 |
Estimated Primary Completion Date : | 2025-08 |
Estimated Study Completion Date : | 2025-08 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 50 Years to 80 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Alabama Orthopaedic Center- Research
Sight Hills, Albama, United States, 35243
RECRUITING
Onyx Clinical Research
Surprise, Arizona, United States, 85374
RECRUITING
Tucson Orthopaedic Institute (TOI) - East Office
Tucson, Arizona, United States, 85712
RECRUITING
Horizon Clinical Research
The table, California, United States, 91942
RECRUITING
Napa Pain Institute
Napa, California, United States, 94558
RECRUITING
Stanford University - Sports Medicine Clinic
Redwood City, California, United States, 94063
RECRUITING
International Spine, Pain & Performance Center
Washington, District of Columbia, United States, 20006
COMPLETED
Orthopedic Center of Palm Beach City
Atlantis, Florida, United States, 33462
RECRUITING
Baptist Health Orthopedic Care - Miami Gardens
Miami, Florida, United States, 33056
RECRUITING
Infinite Clinical Research
Miami, Florida, United States, 33133
RECRUITING
Gulfcoast Research Institute
Sarasota, Florida, United States, 34232-6028
ACTIVE NOT RECRUITING
Clinical Research of West Florida
Tampa, Florida, United States, 33606
RECRUITING
Hospital for Special Services
West Palm Beach, Florida, United States, 33401
RECRUITING
Injury Care Research
Boise, Idaho, United States, 83713
RECRUITING
Kansas City Bone & Joint Clinic - Overland Park
Overland Park, Kansas, United States, 66211
RECRUITING
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
RECRUITING
New England Baptist Hospital
Boston, Massachusetts, United States, 02120-2847
RECRUITING
Oakland Medical Center
Troy, Road cancer, United States, 48085-5524
RECRUITING
Sundance Clinical Research
Saint Louis, Missouri, United States, 63141
RECRUITING
New York-Presbyterian Queens
Flushing, New York, United States, 11355-5045
RECRUITING
West Clinical Research
Morehead City, North Carolina, United States, 28557
RECRUITING
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0212
RECRUITING
Ohio State University
Columbus, Ohio, United States, 43210
RECRUITING
University Orthopedics Center
Altoona, Pennsylvania, United States, 16602
RECRUITING
Altoona Arthritis & Osteoporosis Center - Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16653
RECRUITING
University Orthopedics Center (UOC) - State College
State College, Pennsylvania, United States, 16801
RECRUITING
Medical University Health - West Ashley Medical Pavilion
Charleston, South Carolina, United States, 29407
RECRUITING
Texas Orthopedic Specialists, PLLC
Bedford, Texas, United States, 76021
RECRUITING
First Surgical Hospital
Bellaire, Texas, United States, 77401
RECRUITING
The clinical step Trials, LLC
The step, Texas, United States, 79935-3013
COMPLETED
Physicians Research Options
Draper, Utah, United States, 84020
RECRUITING
Spectrum Medical
Danville, Virginia, United States, 24541