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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
19
Single intra-articular injection
Single intra-articular injection
Area Under the Curve of the Change From Baseline in the Weekly Mean of the Daily Shoulder Pain With Movement
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Time frame: Baseline to 8 weeks
Change From Baseline in the Weekly Mean of the Average Daily Shoulder Pain With Movement Score
The pain intensity score is measured using an 11-point numeric rating scale (NRS), where 0 indicates "No pain" and 10 indicates "Worst possible pain."
Time frame: Baseline to 12 weeks
Change From Baseline in the SPADI Pain Subscale at Week 12
Shoulder Pain and Disability Index (SPADI) Pain scale is measured using 5 11-point NRS questions where 0 indicates "no pain" and 10 indicates "worst pain imaginable." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Time frame: Baseline to 12 weeks
Change From Baseline in the SPADI Disability Subscale at Week 12
Shoulder Pain and Disability Index (SPADI) Disability scale is measured using 8 11-point NRS questions where 0 indicates "no difficulty" and 10 indicates "so difficult it requires help." The Pain and Disability Subscales are presented as a percentage of the total possible score. The Total SPADI score ranges from 0 (best) to 100 (worst) is computed by taking the means of the Pain and Disability Subscale scores.
Time frame: Baseline to 12 weeks
Patient Global Impression of Change (PGIC) Score at Week 12
PGIC is measured using a 7-point NRS where 1 indicates "very much improved" and 7 indicates "very much worse."
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Central Research Associates
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Affinity Orthopedic Specialists
Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
Arizona Research Center
Phoenix, Arizona, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
TriWest Research Associates
El Cajon, California, United States
CORE Orthopedic Medical Center
Encinitas, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
Mountain View Clinical Research Center
Denver, Colorado, United States
...and 17 more locations
Time frame: Baseline to 12 weeks
Change From Baseline in the Range of Motion (ROM) of Active External Rotation at Week 12
Measured using a goniometer which is a device that measures ROM joint angles
Time frame: Baseline to 12 weeks