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News Breaks
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November 12, 2009
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| 08:02 EDT |  | OPTR |
| theflyonthewall.com: | Optimer Pharm completes enrollment in Fidaxomicin Phase 3 trial | | Optimer Pharmaceuticals has completed enrollment in the second of two pivotal Phase 3 clinical trials evaluating the safety and efficacy of fidaxomicin for the treatment of Clostridium difficile infection, or CDI. The Company previously reported positive data from the first Phase 3 trial which showed that fidaxomicin met its primary endpoint of non-inferiority of clinical cure compared to Vancocin. The second Phase 3 trial is a multi-center, randomized, double-blind clinical trial comparing the safety and efficacy of fidaxomicin to that of oral vancomycin in subjects suffering from CDI. This study, which enrolled 536 adult subjects providing 90% power to assess the primary endpoint of clinical cure, was conducted in approximately 100 clinical sites throughout North America and Europe. The study is designed to evaluate safety and compare the response to treatment by subjects during and after a 10-day course of therapy for cure, which is the primary endpoint. If cured, subjects are followed for a subsequent four-week period to evaluate recurrence, which is a secondary endpoint. Global cure, defined as cure with no recurrence, is also a secondary endpoint. :theflyonthewall.com |
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