Study start date: February 2010
Study completion date:*
Phase of development: Phase II
Status: Enrollment
Diagnosis and main inclusion criteria: patients aged 18–60 with uncomplicated influenza lasting no more than 2 days at the moment of enrollment.
Background: Triazavirin is a direct-acting antiviral drug intended for treatment of influenza including avian and pandemic (A/H1N1/2009) flu. Triazavirin is produced in capsules. (Permission for Clinical Trials of Medical Products # 581 of December 12, 2009 given by the Federal Service «Roszdravnadzor» under Ministry of Health and Social Development of the Russian Federation).
Objectives: To assess safety and efficacy of Triazavirin in influenza patients.
Study design: Volunteers are assigned into 2 groups for Triazavirin treatment (2 dosage schemes) and 1 placebo group. In addition, every patient receives symptomatic therapy based on clinical picture and prescribed by the physician-investigator. The study includes the following stages: selection of volunteers based on inclusion/exclusion criteria, and treatment period. During 7 day treatment, patients receive prescribed medication and visit the physician-investigator for a medical checkup at certain dates. The study lasts for 14 days for every study patient of every group involving 4 visits to the study site (RII Clinical Department).
