CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 626 enrolled
Drug / intervention
Zanamivir +3 moredrug
Likely dose
Zanamivir 10 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.

Search/NCT01231620
NCT01231620Phase 3Completed
CompareCT.gov

A Phase III International, Randomized, Double-blind, Double-dummy Study to Evaluate the Efficacy and Safety of 300 mg or 600 mg of Intravenous Zanamivir Twice Daily Compared to 75 mg of Oral Oseltamivir Twice Daily in the Treatment of Hospitalized Adults and Adolescents With Influenza

GlaxoSmithKline·interventional·Posted Nov 1, 2010·Updated Oct 15, 2018

In Brief

A Phase 3 clinical trial evaluating Zanamivir, Placebo to match zanamivir, and 2 other interventions for Influenza, Human. Completed, enrolled 626 participants across 170 sites in 28 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza, Human
CountriesAustralia, 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, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2010
Enrollment StartJan 15, 2011
Primary CompletionMar 18, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.7 years ago

Interventions

Zanamivirdrug

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

Placebo to match zanamivirdrug

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

Oseltamivirdrug

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

Placebo to match oseltamivirdrug

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