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Clinical Trials

Oscient Pharmaceuticals completes enrollment in Phase IV trial of Factive

Published in Medical Letter on the CDC and FDA, February 25th, 2007

Oscient Pharmaceuticals Corporation (OSCI) has completed enrollment in its Phase IV post-marketing trial for its fluoroquinolone antibiotic, Factive (gemifloxacin mesylate) tablets.

Known as the FORCE trial (FACTIVE Outpatient Respiratory Infection Community Experience), Oscient began enrollment coincident with the launch of Factive in the fall of 2004. A commitment to complete post-marketing trials has become a condition of approval for many drugs and this trial was expected to take three to four years to complete. Patient enrollment at more than 200 clinical sites was completed nearly one year ahead of schedule, which allows for the submission of the study report to...

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