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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Influenza, Human

Intervention: CS-8958 (Drug); CS-8958 (Drug); oseltamivir phosphate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Daiichi Sankyo Co., Ltd.

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time to Alleviation of Influenza Illness

Secondary outcome: Time for Body Temperature to Return to Normal

Eligibility

Minimum age: 20 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Hong-Kong, China

Tokyo, Japan

Seoul, Korea, Republic of

Taipei, Taiwan

Additional Information

Starting date: November 2008
Last updated: November 29, 2011

Page last updated: August 23, 2015

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