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
Vestavia Hills, Alabama, United States, 35243
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Horizon Clinical Research
The Table, California, United States, 91942
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International Spine, Pain & Performance Center
Washington, District of Columbia, United States, 20006
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Clinical Research of West Florida
Tampa, Florida, United States, 33606
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Injury Care research
Boise, Idaho, United States, 83713
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Sundance Clinical Research
St. Louis, Missouri, United States, 63141
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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
NOT YET RECRUITING
Physicians Research Options
Draper, Utah, United States, 84020
RECRUITING
Physicians' Research Options, LLC
Draper, Utah, United States, 84020
RECRUITING
Spectrum Medical
Danville, Virginia, United States, 24541