Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis

Adhesive Capsulitis Clinical Trial

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis (RANGE)

Status Terminated

Clinical Trial Summary

This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).

Clinical Trial Description

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in separate cohorts of patients with a documented history of either glenohumeral OA or shoulder AC. Glenohumeral OA and shoulder AC patients will be randomized to receive a single intra-articular injection of either FX006 or placebo (saline) in a 1:1 ratio to the index shoulder with a 24-week Treatment Evaluation Period. Glenohumeral OA patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 numeric rating scale [NRS]). Shoulder AC patients will be stratified by Baseline average daily shoulder pain with movement score according to the following classifications: 5.0 to <7.0 or ≥7.0 to 9.0 (0 to 10 NRS), and by pain duration since onset (1 to 3 months, inclusive, or >3 to ≤6 months). A Home Exercise Program will be implemented 3 days following injection for shoulder AC patients. ;

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Osteoarthritis
• Osteoarthritis of the Shoulder

• NCT number: NCT04160091
• Study type: Interventional
• Source: Pacira Pharmaceuticals, Inc
• Status: Terminated
• Phase: Phase 2
• Start date: November 7, 2019
• Completion date: June 15, 2020