A Study to Evaluate the Efficacy and Safety of ZILRETTA in Subjects With Glenohumeral Osteoarthritis
Pacira Pharmaceuticals, Inc
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
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 150 male or female subjects, 50 to 80 years of age inclusive, will be enrolled, randomized to 1 of 2 treatment groups (2:1), and treated with a single IA injection of either: * Treatment Arm: 32 mg ZILRETTA, * Treatment Arm: plac…
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria To be included in the trial, participants must fulfill the following criteria: 1. Written informed consent has been obtained prior to initiating any study-specific procedures. 2. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions, including eDiary questionnaire completion requirements. 3. Participants 50 to 80 years of age, inclusive, on the day of consent. 4. Body mass index (BMI) does not prohibit proper identification of bony landmarks and/or otherwise prohibit the ability to properly inj…
Interventions
- DrugZILRETTA
IA injection of 32 mg ZILRETTA
- OtherPlacebo
IA injection of placebo (normal saline)
Locations (32)
- Alabama Orthopaedic Center- ResearchVestavia Hills, Alabama
- Onyx Clinical ResearchSurprise, Arizona
- Tucson Orthopaedic Institute (TOI) - East OfficeTucson, Arizona
- Horizon Clinical ResearchLa Mesa, California
- Napa Pain InstituteNapa, California
- Stanford University - Sports Medicine ClinicRedwood City, California