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

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Drug: CS-8958; Drug: oseltamivir phosphate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00803595

CS8958-A-J301

Details and patient eligibility

About

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.

Enrollment: 1,002 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,002 participants in 3 patient groups

CS-8958 Low Dose

Experimental group

Description:

CS-8958 powder to be inhaled - low-dose arm

Treatment:

Drug: CS-8958

Drug: CS-8958

CS-8958 High Dose

Experimental group

Description:

CS-8958 powder to be inhaled - high-dose arm

Treatment:

Drug: CS-8958

Drug: CS-8958

Oseltamivir phosphate

Active Comparator group

Description:

oseltamivir phosphate oral capsules

Treatment:

Drug: oseltamivir phosphate