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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00803595
First received: December 4, 2008
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Influenza, Human
 Drug: CS-8958
Drug: oseltamivir phosphate
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Time to Alleviation of Influenza Illness [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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:
  • Time for Body Temperature to Return to Normal [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 1002
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803595

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

No publications provided by Daiichi Sankyo Inc.

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

Responsible Party: Daiichi Sankyo Inc. ( Daiichi Sankyo Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00803595     History of Changes
Other Study ID Numbers: CS8958-A-J301
Study First Received: December 4, 2008
Results First Received: October 12, 2011
Last Updated: November 29, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare
Hong Kong: Department of Health
Taiwan: Department of Health
Korea: Food and Drug Administration

Keywords provided by Daiichi Sankyo Inc.:
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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013