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Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza

NCT01793883 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 639

Last updated 2018-05-31

Study results available
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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.

Conditions

Interventions

DRUG

40 mg Laninamivir Octanoate

DRUG

80 mg Laninamivir Octanoate

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • John Lambert, PhD · Biota Scientific Management Pty Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Bulgaria
  • Canada
  • Colombia
  • Estonia
  • France
  • Germany
  • Hungary
  • Latvia
  • Mexico
  • New Zealand
  • Peru
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01793883 on ClinicalTrials.gov