The study will identify the efficacy of Apitox, purified honeybee toxin, in 330 patients with diagnosed osteoarthritis of the knee. The subjects will be evaluated for relief of pain using Western Ontario and McMaster Osteoarthritis Index (WOMAC) and Physician and Patient Global Assessments and primary efficacy measure of relief of pain and inflammation over a 12 week treatment period after randomization into the trial. Secondary efficacy is improvement of mobility Treatment effect will be compared in a 2-1 Apitox vs active control
feasibility and Site selection has been completed in the US and India
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
363
intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
imitates pain and erythema of honeybee venom
Functional Research LLC
Gulf Shores, Alabama, United States
Tucson Orthopaedic Institute
Tucson, Arizona, United States
SC Clinical Research Inc.
WOMAC
WOMAC
Time frame: from 4 wks dose escalation thru 12 weeks treatment dose to 4 wks follow up
PhGA
physcians global assessment
Time frame: from 4 wks global assessment through 12 wks
PGA
patients global assessmen
Time frame: from 4 wks throught the 12 wk treatment
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