A 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

Trial Profile

A 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

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Apr 2018

At a glance

  • Drugs Fidaxomicin (Primary) ; Vancomycin
  • Indications Clostridium-difficile-infections; Diarrhoea
  • Focus Registrational; Therapeutic Use
  • Acronyms SUNSHINE
  • Sponsors Astellas Pharma Europe Ltd
  • Most Recent Events

    • 17 Apr 2018 Status changed from active, no longer recruiting to completed.
    • 17 Mar 2018 The study has been completed in France.
    • 14 Mar 2018 The study has been completed in Spain.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top