NCT02116972

Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

A Double-Blind, Randomized, Parallel Group, Dose-Ranging 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 2
• Study type: Interventional
• Enrollment: 310 (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 magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Detailed description

This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of: * 16 mg FX006, * 32 mg FX006, or * normal saline (placebo). 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 over approximately 6 to 7 months.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	FX006 32 mg	Single 5 mL IA injection
DRUG	Placebo	Single 5 mL IA injection
DRUG	FX006 16 mg	Single 5 mL IA injection

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2014-04-17
• Last updated: 2024-01-24
• Results posted: 2018-03-20

Locations

44 sites across 2 countries: United States, Canada