Phase 3
Completed N=1,002
A Multinational Phase III Study of CS-8958 (MARVEL)
Influenza, Human
Source: ClinicalTrials.gov NCT00803595 ↗
Enrolled (actual)
1,002
Serious AEs
0.2%
Results posted
Nov 2011
Primary outcomePrimary: Time to Alleviation of Influenza Illness — 73.0; 85.8; 73.6 hours — p=0.748
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Alleviation of Influenza Illness |
73.0; 85.8; 73.6 | 0.748 |
| SECONDARY Time for Body Temperature to Return to Normal |
55.3; 58.0; 54.7 | 0.318 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00803595). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.