Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 486
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

Detailed description:
This study was a double-blind, randomized, single dose design. The study was conducted in male and female patients ≥40 years of age with OA of the knee. Approximately 450 patients with OA of the knee were randomized to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 32 mg FX006,
* normal saline (placebo), or
* 40 mg TCA IR.

Randomization was stratified by weekly mean of the average daily (24-hour) pain intensity (ADP) scores at baseline, with the following classifications: 5 to \<6, 6 to \<7, and ≥7.

Each patient was evaluated for a total of 24 weeks following a single IA injection. Following screening, safety and efficacy were evaluated at 7 out-patient visits (Days 1 \[baseline\], Weeks 4, 8, 12, 16, 20, and 24). The study was expected to enroll in approximately 6 months.

Arms:
arm 1: Single 5 mL intra-articular (IA) injection Extended-release Formulation arm 2: Single 5 mL intra-articular (IA) injection arm 3: Single 1 mL intra-articular (IA) injection TCA IR 40 mg: Immediate-release formulation

Interventions: intervention 1: FX006 intervention 2: Placebo intervention 3: TCA IR 40
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 5 mL IA injection intervention 3: Single 1 mL IA injection

Protocol document: