Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1002 participants
INTERVENTIONAL
2008-11-30
2009-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CS-8958 Low Dose
CS-8958 powder to be inhaled - low-dose arm
CS-8958
CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
CS-8958 High Dose
CS-8958 powder to be inhaled - high-dose arm
CS-8958
CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
Oseltamivir phosphate
oseltamivir phosphate oral capsules
oseltamivir phosphate
CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.
Interventions
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CS-8958
CS-8958 powder 20 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
CS-8958
CS-8958 powder 40 mg to be inhaled one time. Oseltamivir phosphate placebo capsules 2 times per day for 5 days
oseltamivir phosphate
CS-8958 placebo powder to be inhaled one time. Oseltamivir phosphate oral capsules taken twice daily for 5 days.
Eligibility Criteria
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Inclusion Criteria
* Axillary temperature of \> or = to 37.5 degrees C
Exclusion Criteria
* Chronic respiratory disease
* Renal dysfunction
20 Years
ALL
No
Sponsors
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Daiichi Sankyo Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Hong Kong, , China
Tokyo, , Japan
Seoul, , South Korea
Taipei, , Taiwan
Countries
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References
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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.
Other Identifiers
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CS8958-A-J301
Identifier Type: -
Identifier Source: org_study_id
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