NCT02468583

Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

A Double-Blind, Randomized, Parallel Group, Proof of Concept Study Comparing FX006 to Kenalog®-40 in Patients With Post-Traumatic Osteoarthritis of the Knee

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pacira Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study was a double-blind, randomized, parallel group, proof of concept study comparing FX006 to Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) in patients with post-traumatic osteoarthritis of the knee.

Detailed description

This study was a double-blind, randomized, parallel group, proof of concept study patients with post-traumatic osteoarthritis (PTOA) of the knee. Approximately 124 eligible patients were intended to be randomized to one of the two treatment groups (1:1) and treated with a single intra-articular (IA) injection of: * 32 mg of FX006 * 40 mg of Kenalog®-40 (triamcinolone acetonide injectable suspension, USP) Each prospective patient underwent a screening evaluation to confirm a diagnosis of PTOA of the knee and concurrence with all other eligibility criteria. Patients were be treated on Day 1 (Baseline) and returned to the clinic at Weeks 4, 8 and 12 for evaluation of safety and efficacy.

Conditions

• Post-traumatic Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	FX006 32 mg	Experimental
DRUG	TCA IR 40 mg	Comparator

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-06-11
• Last updated: 2024-01-24
• Results posted: 2017-12-21

Locations

1 site across 1 country: United States