A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Trial Profile

A Phase 3, Multicenter, Randomized, Double-blind Study of a Single Dose of S-033188 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Otherwise Healthy Patients With Influenza

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2017

At a glance

  • Drugs S 033188 (Primary) ; Oseltamivir
  • Indications Influenza virus infections
  • Focus Registrational; Therapeutic Use
  • Acronyms CAPSTONE 1
  • Sponsors Shionogi
  • Most Recent Events

    • 24 Jul 2017 According to a Shionogi media release, based on the results from CAPSTONE-1, Shionogi plans to submit a New Drug Application (NDA) to the PMDA in Japan later this year.
    • 24 Jul 2017 Primary endpoint has been met. (Time to alleviation of symptoms), according to a Shionogi media release.
    • 24 Jul 2017 Top-line results published in a Shionogi media release.
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