Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 229
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Single 3 mL intra-articular (IA) injection Extended-Release Formulation arm 2: Single 3 mL intra-articular (IA) injection Extended-Release Formulation arm 3: Single 3mL intra-articular (IA) injection Extended-Release Formulation arm 4: Single 1 mL intra-articular (IA) injection Immediate-Release Triamcinolone Acetonide

Interventions: intervention 1: FX006 intervention 2: TCA IR
Intervention descriptions: intervention 1: Single 3 mL intra-articular injection intervention 2: Single 1 mL intra-articular injection

Protocol document: