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A Multinational Phase III Study of CS-8958 (MARVEL) (MARVEL)
This study has been completed.
Sponsor:
Daiichi Sankyo Co., Ltd.
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
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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 Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, 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:
Further study details as provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803595
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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | 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 |
Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
|
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 Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 18, 2017