Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee corticosteroid intra-articular injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 24
Healthy volunteers: no

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

Detailed description:
This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

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 3 mL intra-articular (IA) injection Extended-release formulation arm 4: Single 1 mL intra-articular (IA) injection Immediate-release formulation

Interventions: intervention 1: FX006 10 mg intervention 2: FX006 40 mg intervention 3: FX006 60 mg intervention 4: TCA IR 40
Intervention descriptions: intervention 1: single 3 mL IA injection intervention 2: single 3 mL IA injection intervention 3: single 3 mL IA injection intervention 4: single 1 mL IA injection

Protocol document: