Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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

    • 02 Oct 2019 According to a Merck media release, the Prescription Drug User Fee Act (PDUFA) for both the applications is set for Jan. 24, 2020.
    • 02 Oct 2019 According to a Merck media release, based on the data of this study, the US Food and Drug Administration (FDA) has accepted two applications for review 1) a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension, and 2) a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides) difficile infections (CDI) in children aged six months or older.
    • 17 Apr 2018 Status changed from active, no longer recruiting to completed.
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