List of Studies

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Study IDStudy TitleLanguage Clinical Study Result Plain Language Summary
2819-CL-0202A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects with Clostridium difficile-associated Diarrhea (The SUNSHINE Study) English


English


2819-CL-3002Phase III Study of OPT-80 – A Randomized, Double-blind, Vancomycin (VCM)-controlled, Parallel-group Comparison Study in Patients with Clostridium Difficile-associated Diarrhea (CDAD) – (Original language of CSR synopsis and Plain Language Summary is Japanese.) Japanese


Japanese


2819-MA-1002A phase IIIb/IV randomized, controlled, open label, parallel group study to compare the efficacy of vancomycin therapy to extended duration fidaxomicin therapy in the sustained clinical cure of Clostridium difficile infection in an older population. English


English


2819-MA-1003Open label study to evaluate the pharmacokinetics of fidaxomicin in Inflammatory Bowel Disease (IBD) Subjects with Clostridium difficile Infection (CDI) English


English


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