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

Phase 2 Completed 310 enrolled Pacira Pharmaceuticals, Inc

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start: 2014-04
Primary completion: 2015-11
Completion: 2015-11

Outcome

Missed primary endpoint

paper The primary end point was not met (LSM change at week 12 -3.1 with FX006 32 mg versus -2.5 with saline placebo; LSM difference [95% confidence interval] -0.58 [-1.22, 0.07]) (P = 0.08). PMID 29088579 ↗

Publications

Conaghan PG, Cohen SB, Berenbaum F, Lufkin J, Johnson JR, Bodick N. Brief Report: A Phase IIb Trial of a Novel Extended-Release Microsphere Formulation of Triamcinolone Acetonide for Intraarticular Injection in Knee Osteoarthritis. Arthritis Rheumatol. 2018 Feb;70(2):204-211. doi: 10.1002/art.40364. Epub 2017 Dec 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Triamcinolone Acetonide	Other / unclassified	16 mg	Other
Subject	Triamcinolone Acetonide	Other / unclassified	32 mg	Other