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The Amoxicillin PULSYS Phase III Trial achieved its clinical goals in the treatment of adults and adolescents with pharyngitis/tonsillitis due to Group A streptococcal infections (strep throat). Advancis Pharmaceutical Corp enrolled 620 adults and adolescents in a randomized, double-blind, multicenter, noninferiority trial in November 2005. Researchers compared the once-daily, 775-mg tablet of Amoxicillin PULSYS for 10 days with 250 mg of penicillin VK 4 times a day for 10 days. The primary desired end point of the trial was bacterial eradication at the "test-of-cure" visit for patients who had completed the protocol, measured by throat cultures before and after treatment. Bacterial eradication at the posttherapy test-of-cure visit among the patients who had completed the protocol was 85% in the Amoxicillin PULSYS group and 83.4% with penicillin. Stan L. Block, MD, an investigator in the study and a professor of clinical pediatrics noted, "The outcomes were achieved through a single-daily-dose administration, a significant factor with the potential to positively impact patient compliance."
Ms. Farley is a freelance medical writer based in Wakefield, RI.