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Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

NCT02008344 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1161

Last updated 2015-11-11

No results posted yet for this study

Summary

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

Conditions

Interventions

DRUG

favipiravir

Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily

DRUG

placebo

Administered twice daily over 5 consecutive days for a total of 10 doses. * Day 1: 1800 mg twice daily (loading doses) * Days 2 through 5: 800 mg twice daily

Sponsors & Collaborators

  • MediVector, Inc.

    collaborator INDUSTRY

  • MDVI, LLC

    lead INDUSTRY

Principal Investigators

  • Carol Epstein, MD · MediVector, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Colombia
  • Dominican Republic
  • El Salvador
  • Guatemala
  • Mexico
  • Peru
  • Puerto Rico

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02008344 on ClinicalTrials.gov