Clinical Trials Resource Center


June 20, 2005

Advancis and Par have issued negative results of a phase III trial of their investigational antibiotic Amoxicillin PULSYS, for the treatment of Group A streptococcal pharyngitis/tonsillitis. Trial data failed to meet their primary non-inferiority endpoint, with 76.6% of patients achieving bacterial eradication at the end of treatment, compared to 88.5% of subjects receiving penicillin. Secondary non-inferiority endpoints were also missed, including clinical cure at the test-of-cure visit and bacterial eradication at the late post-therapy visit. This open-label study enrolled 353 patients, who received either 775 mg Amoxycillin PULSYS once-daily for seven days or 250 mg penicillin VK four times daily for ten day. The companies anticipate that these results will delay NDA filing by at least 1 year.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.