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NCT01231620 · ClinicalTrials.gov registry record · Phase 3
A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza
A Phase 3 study of Influenza, Human, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 626
- Enrollment target
- 20
- Study locations
NCT01231620: Completed Phase 3 study of Influenza, Human, sponsored by GlaxoSmithKline.
NCT01231620 is a Phase 3 study of Influenza, Human that has completed, run by GlaxoSmithKline. The registered enrollment target is 626 participants, below the 16,189-participant average among 18 other Influenza, Human trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01231620, a Phase 3 study of Influenza, Human, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 626 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Clinical response is defined as the resolution of at least 4 of the 5 vital signs (temperature, oxygen saturation, respiratory status, heart rate, systolic blood pressure) within the respective resolution criteria, maintained for at least 24 hours, or hospital discharge, whichever occurred first. This analysis was performed for Influenza positive population, for those with symptom onset less than or equal to (\<=) 4 days, and for those on mechanical (mech) ventilation or in intensive care unit (
Conditions Studied
Interventions
- DRUG Oseltamivir
- DRUG Zanamivir
- DRUG Placebo to match zanamivir
- DRUG Placebo to match oseltamivir
Study Locations (20)
California
- GSK Investigational Site - Chula Vista
- GSK Investigational Site - Escondido
- GSK Investigational Site - Fullerton
- GSK Investigational Site - La Jolla
- GSK Investigational Site - La Mesa
- GSK Investigational Site - Oceanside
Florida
- GSK Investigational Site - Orlando
- GSK Investigational Site - Sarasota
- GSK Investigational Site - Sunrise
Illinois
- GSK Investigational Site - Chicago
- GSK Investigational Site - Oak Park
- GSK Investigational Site - Peoria
Georgia
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Augusta
Alabama
- GSK Investigational Site - Birmingham
Arizona
- GSK Investigational Site - Phoenix
Colorado
- GSK Investigational Site - Aurora
Connecticut
- GSK Investigational Site - Stamford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2011-01-15 |
| Est. Completion | 2015-03-18 |
| Phase | Phase 3 |
What the finished NCT01231620 record still lists
NCT01231620 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 16,189-participant average among 18 other Influenza, Human trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 4 interventions - of which Oseltamivir is the first listed.
NCT01231620 names 20 study sites across 10 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01231620 about?
NCT01231620 is a clinical study titled "A Study of Intravenous Zanamivir Versus Oral Oseltamivir in Adults and Adolescents Hospitalized With Influenza". 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.
What is the current status of trial NCT01231620?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2011-01-15. Estimated completion is 2015-03-18.
What conditions does trial NCT01231620 study?
This clinical trial studies the following conditions: Influenza, Human.
What interventions are being tested in trial NCT01231620?
The interventions under investigation include: Oseltamivir (DRUG), Zanamivir (DRUG), Placebo to match zanamivir (DRUG), Placebo to match oseltamivir (DRUG).
Who is sponsoring clinical trial NCT01231620?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01231620 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza, Human
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01231620's enrollment target sits among peer trials
626 10th of 18 higher than 9 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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