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news.NicOx has completed patient enrolment in its first phase III trial for HCT 3012 in osteoarthritis ahead of schedule.
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The randomization of 820 patients with osteoarthritis (OA) of the knee at 120 clinical sites in the US was initiated in late December 2005 and has now been completed ahead of the projected timelines. Results from the phase III trial are anticipated in the fourth quarter of 2006.
HCT 3012 is a novel, proprietary, nitric oxide-donating derivative of naproxen, which NicOx aims to develop as the drug of choice for osteoarthritis patients, particularly those with coexisting hypertension, a key cardiovascular risk in up to 40% of the OA population.
The trial is designed to demonstrate that HCT 3012 is superior to placebo and as effective as naproxen in relieving the signs and symptoms of osteoarthritis, in addition to showing that HCT 3012 has no detrimental effect on blood pressure, unlike all other non-steroidal anti-inflammatory drugs (NSAIDs).
An additional trial was recently initiated, using ambulatory blood pressure monitoring (ABPM) to compare the 24-hour blood pressure profile of HCT 3012 and naproxen in hypertensive subjects.
“We have made great efforts to recruit high quality clinical sites for this trial and have encountered a very strong interest among investigators towards HCT 3012 and our goal of establishing this product as the reference drug for millions of osteoarthritis patients,” said Dr Maarten Beekman, vice president of clinical development at NicOx.