NCT01487161

Study of FX006 in Patients With Osteoarthritis of the Knee

A Double-Blind, Randomized, Parallel Group, Dose-Ranging Study Comparing FX006 to Commercially Available Triamcinolone Acetonide Injectable Suspension in Patients With Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety, efficacy and pharmacokinetics of FX006 in patients with osteoarthritis of the knee.

Detailed description

Study FX006-2011-001 was a multi-center, randomized, double-blind, active comparator, parallel-group, single-dose study designed to assess the magnitude and duration of pain relief of three doses (10, 40, and 60 mg) of FX006, an extended-release formulation of TCA, relative to commercially-available TCA IR. The general tolerability of a single injection of FX006 also was assessed. Secondary objectives included exploration of the effect of FX006 on functional improvement, responder status, time to onset of pain relief, global impressions of change, and consumption of analgesic medications and evaluation of the PK profile of single injection of the three dose levels of FX006. The study was planned to be conducted in up to 224 male and female patients ≥40 years of age with OA of the knee enrolled at 22 study centers in the US, Australia, and Canada.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	FX006	Single 3 mL intra-articular injection
DRUG	TCA IR	Single 1 mL intra-articular injection

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2011-12-07
• Last updated: 2024-01-24
• Results posted: 2018-01-12

Locations

21 sites across 3 countries: United States, Australia, Canada