At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,184 enrolled
Drug / intervention
Baloxavir Marboxil +3 moredrug
Likely dose
Not stated in 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 Compared With Placebo or Oseltamivir 75 mg Twice Daily for 5 Days in Patients With Influenza at High Risk of Influenza Complications
In Brief
A Phase 3 clinical trial evaluating Baloxavir Marboxil, Placebo to Baloxavir Marboxil, and 2 other interventions for Influenza. Completed, enrolled 2,184 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 improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 2016
Enrollment StartJan 2017
Primary CompletionApr 2018
Study CompletionApr 2018
TodayJul 2026
First PostedOct 31, 2016
Enrollment StartJan 11, 2017
Primary CompletionApr 12, 2018
Study CompletionApr 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 9.7 years ago
Interventions
Baloxavir Marboxildrug
Tablets taken orally
Placebo to Baloxavir Marboxildrug
Matching tablets taken orally
Oseltamivirdrug
Capsules taken orally
Placebo to Oseltamivirdrug
Matching placebo capsules taken orally