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

Phase 3

Completed

• Conditions: Influenza, Human
• Interventions: Drug: CS-8958; Drug: oseltamivir phosphate

• Registration Number: NCT00803595
• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-12-04
• Study First Submitted QC: 2008-12-04
• Study First Posted: 2008-12-05
• Primary Completion: 2009-03
• Study Completion: 2009-06
• Results First Submitted: 2011-10-12
• Results First Submitted QC: 2011-10-12
• Status Verified: 2011-11
• Results First Posted: 2011-11-22
• Last Update Submitted: 2018-12-20
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1002

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CS-8958 Low Dose	CS-8958	CS-8958 powder to be inhaled - low-dose arm
CS-8958 High Dose	CS-8958	CS-8958 powder to be inhaled - high-dose arm
Oseltamivir phosphate	oseltamivir phosphate	oseltamivir phosphate oral capsules

Primary Outcome Measures

Name	Time	Method
Time to Alleviation of Influenza Illness	15 days	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.

Secondary Outcome Measures

Name	Time	Method
Time for Body Temperature to Return to Normal	15 days	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.