ZILRETTA in Subjects With Glenohumeral Osteoarthritis

Status Recruiting

Clinical Trial 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, 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

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06269705
Study type	Interventional
Source	Pacira Pharmaceuticals, Inc
Contact	Jennifer Gordon
Phone	973-451-4055
Email	jennifer.gordon@pacira.com
Status	Recruiting
Phase	Phase 3
Start date	February 5, 2024
Completion date	August 2025

View Details

See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04845074` - Prosthesis Versus Active Exercise Program in Patients With Glenohumeral Osteoarthritis	N/A
Terminated	`NCT03586687` - Osteoarthritis Shoulder Injection Study	Phase 4
Completed	`NCT03379545` - 3D MR Versus 3D CT for Glenohumeral Arthritis	N/A
Active, not recruiting	`NCT06171542` - Efficacy of a Single Image Guided Injection of CTM for Glenohumeral Arthritis	Phase 1
Completed	`NCT00436969` - ORTHOVISC Shoulder Osteoarthritis Study	Phase 3
Recruiting	`NCT03869229` - Adipose-derived Mesenchymal Stem Cells in Osteoarthritis	Phase 1/Phase 2
Completed	`NCT00500630` - Objective Evaluation of Shoulder Pathology and Surgery	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.