deltatrials
Completed PHASE3 INTERVENTIONAL 5-arm NCT02954354

A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza (CAPSTONE 1)

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

Sponsor: Shionogi

Conditions Influenza
Interventions Baloxavir Marboxil Oseltamivir Placebo to Baloxavir Marboxil Placebo to Oseltamivir
Updated 14 times since 2017 Last updated: Apr 24, 2019 Started: Dec 8, 2016 Primary completion: Apr 4, 2017 Completion: Apr 24, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02954354, this PHASE3 trial focuses on Influenza and remains completed. Sponsored by Shionogi, it has been updated 14 times since 2016, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~Apr 2017 · 31 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Feb 2018 · 8 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Dec 2018 · 4 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Jun 2019 · 5 months · monthly snapshot~Jun 2019 – ~Jan 2021 · 19 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 22 months · monthly snapshot

Change History

14 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  4. Jun 2019 — Jan 2021 [monthly]

    Completed PHASE3

  5. Jan 2019 — Jun 2019 [monthly]

    Completed PHASE3

▶ Show 9 earlier versions

  1. Dec 2018 — Jan 2019 [monthly]

    Completed PHASE3

  2. Aug 2018 — Dec 2018 [monthly]

    Completed PHASE3

  3. Jun 2018 — Aug 2018 [monthly]

    Completed PHASE3

  4. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE3

  5. Jun 2017 — Feb 2018 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  6. Apr 2017 — Jun 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  7. Mar 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting

  8. Feb 2017 — Mar 2017 [monthly]

    Not Yet Recruiting PHASE3

  9. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting PHASE3

    First recorded

Dec 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Shionogi
Data source: Shionogi Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

No location information available.