NCT02357459

Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 486 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	FX006	Single 5 mL IA injection
DRUG	Placebo	Single 5 mL IA injection
DRUG	TCA IR 40	Single 1 mL IA injection

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-02-06
• Last updated: 2024-01-24
• Results posted: 2018-02-01

Locations

38 sites across 8 countries: United States, Australia, Canada, Denmark, Estonia, Hong Kong, Lithuania, Romania