CLINICAL TRIALS PROFILE FOR FIDAXOMICIN
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All Clinical Trials for fidaxomicin
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00314951 ↗ | Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) | Completed | Optimer Pharmaceuticals LLC | Phase 3 | 2006-05-02 | This is a comparative study to investigate the safety and efficacy of fidaxomicin versus vancomycin in subjects with Clostridium difficile-Associated Diarrhea (CDAD). |
| NCT00468728 ↗ | PAR-101/OPT-80 Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) | Completed | Optimer Pharmaceuticals LLC | Phase 3 | 2006-10-04 | This is a comparative study to investigate the safety and efficacy of PAR-101/OPT-80 (fidaxomicin) versus vancomycin in subjects with Clostridium difficile-associated diarrhea (CDAD). |
| NCT01552668 ↗ | Fidaxomicin to Prevent Clostridium Difficile Colonization | Withdrawn | Centers for Disease Control and Prevention | Phase 4 | 2012-09-01 | The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection. |
| NCT01552668 ↗ | Fidaxomicin to Prevent Clostridium Difficile Colonization | Withdrawn | Washington University School of Medicine | Phase 4 | 2012-09-01 | The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection. |
| NCT01591863 ↗ | Safety, Tolerability, and Pharmacokinetics of Fidaxomicin in Pediatric Subjects With Clostridium Difficile-associated Diarrhea (CDAD) | Completed | Optimer Pharmaceuticals LLC | Phase 2 | 2012-06-15 | The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of fidaxomicin in pediatric subjects with Clostridium difficile-associated diarrhea (CDAD). |
| NCT01691248 ↗ | Safety and Efficacy of Fidaxomicin Versus Placebo for Prophylaxis Against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation (MK-5119-001) | Completed | Optimer Pharmaceuticals LLC | Phase 3 | 2012-10-10 | The objective of this study is to demonstrate the efficacy and safety of Fidaxomicin versus placebo for prophylaxis against Clostridium difficile-Associated Diarrhea (CDAD) in adult participants undergoing hematopoietic stem cell transplantation (HSCT). The primary hypothesis is that Fidaxomicin is superior to placebo in preventing CDAD in participants undergoing HSCT. |
| NCT01775397 ↗ | A Post-marketing, Blinded Study to Investigate How Effective Fidaxomicin is Compared to Vancomycin in the Sustained Cure of Clostridium Difficile Infection in Adults That Are Receiving Therapy to Suppress the Immune System | Terminated | Cubist Pharmaceuticals LLC | Phase 4 | 2012-11-29 | The primary objective is to compare fidaxomicin versus vancomycin for the sustained clinical cure of Clostridium difficile Infection (CDI) in adult patients receiving immunosuppressive therapy. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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