Study of FX006 in Patients With Osteoarthritis of the Knee

Summary

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

Timeline

Start

2012-06

Primary completion

2013-04

Completion

2013-04

Outcome

Missed primary endpoint

registry analysis (superiority test); FX006 60 mg vs TCA IR 40 mg; p = 0.1249 NCT01487161 ↗

registry analysis (superiority test); FX006 60 mg vs TCA IR 40 mg; p = 0.2002 NCT01487161 ↗

registry analysis (superiority test); FX006 60 mg vs TCA IR 40 mg; p = 0.5541 NCT01487161 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	TCA IR	Unknown	40 mg	Other
Subject	Tafamidis	Unknown	10 mg	Other
Subject	Tafamidis	Unknown	40 mg	Other
Subject	Tafamidis	Unknown	60 mg	Other

Indications