A Multinational Phase III Study of CS-8958 (MARVEL)

A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection

The primary objective of this study is to confirm the efficacy of CS-8958 administered as a single inhaled low dose or single inhaled high dose by showing non-inferiority to oseltamivir phosphate using the time to alleviation of influenza illness. For safety evaluation, between-group comparisons will be made with regard to incidence of adverse events and other safety measures.

In a secondary objective, the optimum dosage of CS-8958 for this indication will be evaluated based on the efficacy and safety of single inhaled low or high dose.

Inclusion Criteria:

• Clinical diagnosis of influenza
• Axillary temperature of > or = to 37.5 degrees C

Exclusion Criteria:

• Infection by bacteria species and/or virus other than influenza virus
• Chronic respiratory disease
• Renal dysfunction