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Generated: June 19, 2019

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CLINICAL TRIALS PROFILE FOR FIDAXOMICIN

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Clinical Trials for Fidaxomicin

Trial ID Title Status Sponsor Phase Summary
NCT00314951 Fidaxomicin Versus Vancomycin for the Treatment of Clostridium Difficile-Associated Diarrhea (CDAD) (MK-5119-018) Completed Optimer Pharmaceuticals LLC Phase 3 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 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NCT01552668 Fidaxomicin to Prevent Clostridium Difficile Colonization Withdrawn Centers for Disease Control and Prevention Phase 4 The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in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NCT01552668 Fidaxomicin to Prevent Clostridium Difficile Colonization Withdrawn Washington University School of Medicine Phase 4 The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in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 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 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 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 Summary

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Clinical Trial Conditions for Fidaxomicin

Condition Name

Condition Name for Fidaxomicin
Intervention Trials
Clostridium Difficile Infection 9
Clostridium Difficile 6
Diarrhea 4
Clostridium Infections 2
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Condition MeSH

Condition MeSH for Fidaxomicin
Intervention Trials
Infection 12
Communicable Diseases 9
Diarrhea 8
Clostridium Infections 3
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Clinical Trial Locations for Fidaxomicin

Trials by Country

Trials by Country for Fidaxomicin
Location Trials
United States 86
United Kingdom 8
Canada 8
Poland 7
France 6
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Trials by US State

Trials by US State for Fidaxomicin
Location Trials
California 6
New York 5
Illinois 5
North Carolina 4
Massachusetts 4
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Clinical Trial Progress for Fidaxomicin

Clinical Trial Phase

Clinical Trial Phase for Fidaxomicin
Clinical Trial Phase Trials
Phase 4 10
Phase 3 8
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for Fidaxomicin
Clinical Trial Phase Trials
Recruiting 9
Completed 9
Not yet recruiting 5
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Clinical Trial Sponsors for Fidaxomicin

Sponsor Name

Sponsor Name for Fidaxomicin
Sponsor Trials
Optimer Pharmaceuticals LLC 5
Cubist Pharmaceuticals LLC 4
Merck Sharp & Dohme Corp. 4
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Sponsor Type

Sponsor Type for Fidaxomicin
Sponsor Trials
Industry 23
Other 20
U.S. Fed 2
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