French Drug Company Conducting Osteoarthritis Treatment Trails, FDA Approval Forthcoming

NicOx S.A of France has all the people in needs for the phase 3 study of naproxcinod. This is commonly known as a 302 study, and researchers are hoping to see the facts of naproxcinod in reducing the symptoms and signs of osteoarthritis. The researchers will be carefully looking at the 1020 patients; it has enrolled in this study.

They will also be looking at the blood pressure, which is very important, when trying to choose between the different anti-inflammatory treatments allowable today for osteoarthritis. They are hoping that the results from the study will be completed in the fall of 2008.

This 302 study, is the biggest of the three phase tryouts for this drug, naproxcinod.

There are three phases to this study, the 301 study is already done, and the results are known within the American College of Rheumatology, which looked at the way this naproxcinod treated the symptoms and signs of osteoarthritis. It also had a positive effect on the systolic blood pressures of those patients who were involved in this study, but some patients got placebo, which was given, with a commonly used anti-inflammatory, which is also given to treat osteoarthritis.
The 302 is the largest, and also the longest trial in the series of the three studies for Naproxcinod, and a clinical team is ready, all the patients are ready, and trail is now underway.

The study will provide 13 and 26 week, efficiency results, so that the doctors and researchers know exactly how well this drug is working for the osteoarthritis patients. The researchers will be watching the blood pressure readings of all these patients, to make sure it does not go up as a result of the medicine. Some anti-inflammatory do increase the blood pressure, and researchers are hoping this will be the one that does not raise the blood pressure.

302 this study is in the process, this is double blind safety trial in which in 1020 patients who have osteoarthritis of the knee, and who have been treated at one of the hundred and 50 different clinics within the United States. The, these patients were randomly chosen to get either of the Naproxinod 375, the naproxinod 750, naproxen, and the placebo for the duration of the trail.

In each visit to patients, blood pressure is checked to ensure there are known increases, because of the medicine.

The third stage, commonly known as the 303 is a 13-week trial, and is now accepting patients with osteoarthritis of the hip, in these patients will be given the drug naproxcinod or a placebo, which controls the symptoms and signs of osteoarthritis in June, the trials, will start and the trial should be finished by December 2008.

Pending the outcome of those studies, the company NICOX S A will then seek approval from the FDA, in the middle of 2009. This drug company is headquartered in France, for more information on this company and its trials please go to www.nicox.com

Source;
http://www.medicalnewstoday.com/articles/91882.php