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A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza

NCT01231620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2018-10-15

Study results available
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Summary

The purpose of this study is to test the safety and efficacy of zanamivir given intravenously and how well it works at two different doses in hospitalized adolescents and adults with flu. Zanamivir will be compared with oseltamivir, which is used for treating flu.

Conditions

  • Influenza, Human

Interventions

DRUG

Zanamivir

Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials.

DRUG

Placebo to match zanamivir

Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume.

DRUG

Oseltamivir

Oseltamivir will be provided as over-encapsulated 75 mg capsules.

DRUG

Placebo to match oseltamivir

Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-15
Primary Completion
2015-03-18
Completion
2015-03-18

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Colombia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hong Kong
  • Hungary
  • India
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Russia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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Entities

Companies

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 NCT01231620 on ClinicalTrials.gov