Ignite Creation Date:
2024-05-06 @ 1:55 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04160091
Status:
TERMINATED
Last Update Posted:
2024-01-24
First Post:
2019-11-08
Brief Title:
Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis
Sponsor:
Pacira Pharmaceuticals Inc
Organization:
Pacira Pharmaceuticals Inc
Study Overview
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
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated prematurely due to the COVID-19 pandemic creating uncertainty impacting trial progress and costs
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 11 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 50 to 70 or 70 to 90 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 50 to 70 or 70 to 90 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None