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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Influenza, Human	Drug: CS-8958; Drug: oseltamivir phosphate	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1002 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection
Study Start Date :	November 2008
Actual Primary Completion Date :	March 2009
Actual Study Completion Date :	June 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Time to Alleviation of Influenza Illness [ Time Frame: 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 :

1. Time for Body Temperature to Return to Normal [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	20 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

China
Hong-Kong, China
Japan
Tokyo, Japan
Korea, Republic of
Seoul, Korea, Republic of
Taiwan
Taipei, Taiwan

Sponsors and Collaborators

Daiichi Sankyo Co., Ltd.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Watanabe A, Chang SC, Kim MJ, Chu DW, Ohashi Y; MARVEL Study Group. Long-acting neuraminidase inhibitor laninamivir octanoate versus oseltamivir for treatment of influenza: A double-blind, randomized, noninferiority clinical trial. Clin Infect Dis. 2010 Nov 15;51(10):1167-75. doi: 10.1086/656802. Epub 2010 Oct 11.

Responsible Party:	Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00803595 History of Changes
Other Study ID Numbers:	CS8958-A-J301
First Posted:	December 5, 2008
Results First Posted:	November 22, 2011
Last Update Posted:	December 5, 2011
Last Verified:	November 2011

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):

Influenza; Neuraminidase inhibitor

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases	Oseltamivir; Antiviral Agents; Anti-Infective Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action