Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-20 @ 5:56 PM
Study NCT ID:
NCT02357459
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2015-02-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Sponsor:
Pacira Pharmaceuticals, Inc
Organization:
Study Overview
Official Title:
A Double-Blind, Randomized, Single-Dose Study to Assess the Safety and Efficacy of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.
Detailed Description:
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:
* 32 mg FX006,
* normal saline (placebo), or
* 40 mg TCA IR.
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.
* 32 mg FX006,
* normal saline (placebo), or
* 40 mg TCA IR.
Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.
Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: