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

Influenza, Human Clinical Trial

— MARVEL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803595
• Other study ID #: CS8958-A-J301
• Status: Completed
• Phase: Phase 3
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: November 2011
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1002
• Est. completion date: June 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo Co., Ltd.

Countries where clinical trial is conducted

China,  Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Alleviation of Influenza Illness	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.	15 days
Secondary	Time for Body Temperature to Return to Normal	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.	15 days