A Multinational Phase III Study of CS-8958 (MARVEL) (MARVEL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00803595|
Recruitment Status : Completed
First Posted : December 5, 2008
Results First Posted : November 22, 2011
Last Update Posted : December 5, 2011
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1002 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Experimental: CS-8958 Low Dose
CS-8958 powder to be inhaled - low-dose arm
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
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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00803595
|Korea, Republic of|
|Seoul, Korea, Republic of|