study of fx006 vs normal saline in patients with osteoarthritis of the knee

Conditions: Osteoarthritis of the Knee

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).

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.

Eligibility criteria:
main inclusion criteria: * willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions * male or female \>=40 years of age * has documented diagnosis of oa of the index knee made at least 6 months prior to screening * currently meets american college of rheumatology (acr) criteria (clinical and radiological) for oa * kellgren-lawrence (k-l) grade 2 or 3 in the index knee per screening x-ray * qualifying mean score on the 24-h average pain score (0-10 numeric rating scale) * body mass index (bmi) ≤ 40 kg/m2 * willingness to abstain from use of restricted medications main exclusion criteria: * ipsilateral hip oa * fibromyalgia, chronic pain syndrome or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee * history of reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis * history of arthritides due to crystals (e.g., gout, pseudogout) * history or clinical signs and symptoms of infection in the index joint * knee pain that is not clinically attributable to oa of the knee (e.g., radicular low back pain and hip pain that is referred to the knee that could cause misclassification) * pain in any other area of the lower extremities or back that is equal to or greater than the index knee pain * ia corticosteroid (investigational or marketed) in any joint within 3 months of screening * ia hyaluronic acid (investigational or marketed) in the index knee within 6 months of screening * intramuscular (im) corticosteroids (investigational or marketed) within 3 months of screening * oral corticosteroids (investigational or marketed) within 1 month of screening * inhaled, intranasal and topical corticosteroids (investigational or marketed) within 2 weeks of screening * any other ia investigational drug/biologic within 6 months of screening * prior use of fx006 * women of child-bearing potential not using effective contraception or who are pregnant or nursing

Keywords: osteoarthritis knee pain corticosteroid intra-articular injection