Study to Compare Exposure of TA Following Administration of FX006 or TAcs

Status Completed

Clinical Trial Summary

This is an open-label study to compare systemic exposure to triamcinolone acetonide following a dose of extended-release FX006 or immediate-release TAcs (triamcinolone acetonide suspension) in patients with osteoarthritis of the shoulder (glenohumeral joint) or hip

Clinical Trial Description

This is a randomized, open-label, single dose study that will be conducted in male and female patients ≥40 years of age with OA of either the shoulder or the hip. Approximately 24 patients with OA of the shoulder and approximately 24 patients with OA of the hip will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either: - 32 mg FX006 (approximately 12 patients per joint) or - 40 mg TAcs (approximately 12 patients per joint) Each patient will be screened to confirm the diagnosis of OA of either the shoulder or hip and eligibility based on the other inclusion/exclusion requirements and will be randomized to treatment on Day 1. Each patient will be evaluated for a total of 12 weeks following the IA injection. Following screening, sampling for pharmacokinetics (PK) and safety will be completed at 10 out-patient visits scheduled on Study Days 1 [calendar day of injection], 2, 3, 5, 8, 15, 22, 29, 57, and 85. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03382262
Study type	Interventional
Source	Pacira Pharmaceuticals, Inc
Contact
Status	Completed
Phase	Phase 2
Start date	December 18, 2017
Completion date	October 9, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05160441` - Comparing Platelet Rich Plasma and Corticosteroid for Military & Civilian Patients With Glenohumeral Osteoarthritis	Phase 3
Suspended	`NCT02204228` - TITAN™ Reverse Shoulder System
Recruiting	`NCT04468178` - Clinical Results and RSA Migration Analysis of the GLOBAL ICON - Stemless Anatomic Shoulder	N/A
Withdrawn	`NCT03770546` - Amnion-Based Injections in the Shoulder	N/A
Active, not recruiting	`NCT05049993` - Pyrocarbon Clinical Follow-up Study
Terminated	`NCT04160091` - Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis	Phase 2
Completed	`NCT00479687` - SUPARTZ Versus Placebo in Osteoarthritis of the Shoulder	N/A
Recruiting	`NCT04228419` - TSA vs RSA in Glenohumeral Osteoarthritis	N/A
Enrolling by invitation	`NCT03404778` - Comprehensive Reverse Shoulder Data Collection
Completed	`NCT02052206` - Reconstruction of Complex Proximal Humeral Fractures.	N/A
Completed	`NCT03887650` - LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs	Phase 4
Active, not recruiting	`NCT04634773` - Unravelling the Etiology of Shoulder Osteoarthritis	N/A
Completed	`NCT01697865` - Reverse Shoulder Arthroplasty With or Without Concomitant Latissimus and Teres Major Transfer for Shoulder Pseudoparalysis With Teres Minor Dysfunction	N/A
Enrolling by invitation	`NCT03806881` - Long Term Follow-up After Primary or Revision Shoulder Arthroplasty With a Patient- Specific Glenius Implant
Active, not recruiting	`NCT01587560` - A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant	N/A
Completed	`NCT03385408` - Effectiveness of HILT in Shoulder Osteoarthritis	N/A
Active, not recruiting	`NCT03097406` - Functional Outcome and Complications After Global Unite ® Prostheses
Active, not recruiting	`NCT03409718` - Database Retrieval for the Comprehensive Shoulder
Withdrawn	`NCT04134442` - Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome	Phase 4
Active, not recruiting	`NCT03726554` - Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty	N/A

Study to Compare Exposure of TA Following Administration of FX006 or TAcs in Patients With OA of the Shoulder or Hip

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms