At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,436 enrolled
Drug / intervention
Baloxavir Marboxil +3 moredrug
Likely dose
Oseltamivir 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Baloxavir Marboxil, Placebo to Baloxavir Marboxil, and 2 other interventions for Influenza. Completed, enrolled 1,436 participants.
Detailed Summary
The primary objective of this study is to evaluate the efficacy of a single, oral dose of baloxavir marboxil compared with placebo by measuring the time to alleviation of symptoms in patients with uncomplicated influenza virus infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedNov 2016
Enrollment StartDec 2016
Primary CompletionApr 2017
Study CompletionApr 2017
TodayJul 2026
First PostedNov 3, 2016
Enrollment StartDec 8, 2016
Primary CompletionApr 4, 2017
Study CompletionApr 24, 2017
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 9.7 years ago
Interventions
Baloxavir Marboxildrug
2 to4 X 20-mg tablets taken orally
Placebo to Baloxavir Marboxildrug
2 to4 X 20-mg tablets taken orally
Oseltamivirdrug
75 mg capsules taken orally
Placebo to Oseltamivirdrug
Placebo capsules matching oseltamivir 75 mg capsules