These trials are designed to assess the blood pressure profile of naproxcinod, in comparison to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring (ABPM) technique. Results of both studies are expected in the fourth quarter of 2008.
The objectives of these Phase I ABPM trials, known as the 111 and 112 studies, are to provide important additional data on the 24-hour blood pressure profile of naproxcinod in chronically treated osteoarthritis (OA) patients with controlled hypertension, in comparison to commonly used non-steroidal anti-inflammatory drugs.
The 111 is a 12-week study, which has enrolled 118 patients at 30 clinical sites, who are receiving increasing doses of either naproxcinod or naproxen at three week intervals.
The 112 study has enrolled 299 patients at 60 clinical sites, which have been randomized to five groups, receiving 13 weeks of treatment with: naproxcinod 375mg bid (twice daily), naproxcinod 750mg bid, naproxen 250mg bid, naproxen 500mg bid or ibuprofen 600mg tid (three times daily).