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

NCT02954354 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1436

Last updated 2019-05-08

Study results available
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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.

Conditions

Interventions

DRUG

Baloxavir Marboxil

2 to4 X 20-mg tablets taken orally

DRUG

Placebo to Baloxavir Marboxil

2 to4 X 20-mg tablets taken orally

DRUG

Oseltamivir

75 mg capsules taken orally

DRUG

Placebo to Oseltamivir

Placebo capsules matching oseltamivir 75 mg capsules

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Clinical Support Help Line Shionogi Clinical Trials Administrator · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-08
Primary Completion
2017-04-04
Completion
2017-04-24

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02954354 on ClinicalTrials.gov