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Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications

NCT02949011 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2184

Last updated 2019-11-19

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 improvement of influenza symptoms in patients with influenza presenting within 48 hours of symptom onset.

Conditions

Interventions

DRUG

Baloxavir Marboxil

Tablets taken orally

DRUG

Placebo to Baloxavir Marboxil

Matching tablets taken orally

DRUG

Oseltamivir

Capsules taken orally

DRUG

Placebo to Oseltamivir

Matching placebo capsules taken orally

Sponsors & Collaborators

  • Shionogi

    lead INDUSTRY

Principal Investigators

  • Shionogi Clinical Trials Administrator Clinical Support Help Line · Shionogi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-11
Primary Completion
2018-04-12
Completion
2018-04-20

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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 NCT02949011 on ClinicalTrials.gov