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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.
• Treatments: Oseltamivir

Criteria

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