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

Osteoarthritis of the Knee Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02116972
Study type Interventional
Source Pacira Pharmaceuticals, Inc
Contact
Status Completed
Phase Phase 2
Start date April 2014
Completion date November 2015
View Details
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