Intra-articular orgotein therapy in osteoarthritis of the knee. A double-blind, placebo-controlled trial

Intra-articular efficacy and long-term safety of orgotein, the drug version of Cu-Zn superoxide dismutase, were explored in a 24-week double-blind, placebo-controlled trial in patients with active osteoarthritis (ARA criteria) of the knee joint. Each patient received twelve intra-articular injections at biweekly intervals of orgotein (2 mg) or placebo dissolved in about 2 ml saline injection, USP. No other antiinflammatory medications were permitted. By the end of the trial, significant efficacy of orgotein over placebo had been reached in the parameters of pain, functional improvement and evaluation of status both by physician and patient. With the orgotein dose regimen used, improvement of disease activity versus time progressed with a fairly constant slope. In the placebo group a surprisingly large initial response was observed which lasted as long as 12 weeks in some instances before subsiding.