NCT00803595

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,002 (actual)
• Sponsor: Daiichi Sankyo Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DRUG	CS-8958	CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
DRUG	CS-8958	CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
DRUG	oseltamivir phosphate	CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-03-01
• Completion: 2009-06-01
• First posted: 2008-12-05
• Last updated: 2019-01-09
• Results posted: 2011-11-22

Locations

4 sites across 4 countries: China, Japan, South Korea, Taiwan