Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis knee pain corticosteroid intra-articular injection
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 310
Healthy volunteers: no

Brief 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).

Detailed description:
This was a double-blind, randomized, parallel group, dose-ranging, single-dose study. The study was conducted in male and female patients ≥40 years of age with OA of the knee.

Approximately 300 patients with OA of the knee were randomized, using a centralized randomization procedure, to 1 of 3 treatment groups (1:1:1) and treated with a single IA injection of:

* 16 mg FX006,
* 32 mg FX006, or
* normal saline (placebo).

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 over approximately 6 to 7 months.

Arms:
arm 1: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 2: Single 5 mL intra-articular (IA) injection Extended-release formulation arm 3: Normal Saline Single 5 mL intra-articular (IA) injection

Interventions: intervention 1: FX006 32 mg intervention 2: Placebo intervention 3: FX006 16 mg
Intervention descriptions: intervention 1: Single 5 mL IA injection intervention 2: Single 5 mL IA injection intervention 3: Single 5 mL IA injection

Protocol document: