protocolSection identificationModule nctId: NCT06269705, orgStudyIdInfo id: 006-C-301, briefTitle: ZILRETTA in Subjects With Glenohumeral Osteoarthritis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2025-08, completionDateStruct date: 2025-08, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Pacira Pharmaceuticals, Inc, class: INDUSTRY, descriptionModule briefSummary: 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 placeboSecondary 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, conditionsModule conditions: Glenohumeral Osteoarthritis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: INVESTIGATOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: ZILRETTA, interventions name: TCA-IR, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 12 for ZILRETTA relative to TCA-IR, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 18 for ZILRETTA relative to TCA-IR, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 2 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 4 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline on the Worst Daily Pain (24-hr) mean score at Week 8 for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to placebo, secondaryOutcomes measure: Change from Baseline at Week 12 on the SPADI total score and subscales for ZILRETTA relative to TCA-IR, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Alabama Orthopaedic Center- Research, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35243, country: United States, contacts name: Robert Sorrell, MD, role: CONTACT, geoPoint lat: 33.52066, lon: -86.80249, hasResults: False