At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 639 enrolled
Drug / intervention
40 mg Laninamivir Octanoate +2 moredrug
Likely dose
40 mg Laninamivir Octanoatefrom 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.
A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Arm Study to Investigate the Efficacy and Safety of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Symptomatic Influenza A or B Infection
In Brief
A Phase 2 clinical trial evaluating 40 mg Laninamivir Octanoate, 80 mg Laninamivir Octanoate, and 1 other intervention for Influenza. Completed, enrolled 639 participants across 221 sites in 16 countries.
Detailed Summary
This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who present to clinic with symptomatic presumptive influenza A or B infection.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesAustralia, Belgium, Bulgaria, Canada, Colombia, Estonia, France, Germany, Hungary, Latvia, Mexico, New Zealand, Peru, South Africa, United Kingdom, United States
CollaboratorsDepartment of Health and Human Services
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMay 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedFeb 18, 2013
Enrollment StartMay 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.4 years ago
Interventions
40 mg Laninamivir Octanoatedrug
80 mg Laninamivir Octanoatedrug
Placebodrug