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

Study Overview
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Brief Summary
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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.

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

Conditions
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Influenza, Human

Intervention / Treatment
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* Drug: CS-8958
* Drug: CS-8958
* Drug: oseltamivir phosphate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CS-8958 Low Dose<br>CS-8958 powder to be inhaled - low-dose arm | Drug: CS-8958<br>* CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days<br>|
| Experimental: CS-8958 High Dose<br>CS-8958 powder to be inhaled - high-dose arm | Drug: CS-8958<br>* CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days<br>|
| Active Comparator: Oseltamivir phosphate<br>oseltamivir phosphate oral capsules | Drug: oseltamivir phosphate<br>* CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Alleviation of Influenza Illness | The time to illness alleviation which was defined as the time from the initiation of trial treatment to the beginning of the first 21.5-h period in which all influenza symptoms were absent or mild. Patients recorded their severity of influenza symptoms (headache, myalgia/arthralgia, fatigue, chills/sweats, nasal symptom, sore throat, and cough) 4 times daily for 15 days. Patients whose influenza symptoms had not been alleviated at the time of their withdrawal from the study or at the end of the observation period were censored. | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Body Temperature to Return to Normal | Time for return to normal axillary temperature was was defined as the time until the beginning of the first 21.5-hour period in which the axillary temperature returned to 36.9°C. Patients recorded their axillary temperature 4 times daily for 15 days. Patients whose axillary temperature had not been returned to 36.9°C at the time of their withdrawal from the study or at the end of the observation period were censored. | 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Influenza, Neuraminidase inhibitor