A Multinational Phase III Study of CS-8958 (MARVEL) (MARVEL)
20. december 2018 opdateret af: Daiichi Sankyo Co., Ltd.
A Randomized Double-blind Controlled Study of CS-8958 Versus Oseltamivir Phosphate in Patients With Influenza Virus Infection
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1002
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tokyo, Japan
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Hong-Kong, Kina
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Seoul, Korea, Republikken
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Taipei, Taiwan
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: CS-8958 Low Dose
CS-8958 powder to be inhaled - low-dose arm
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CS-8958 powder 20 mg to be inhaled one time.
Oseltamivir phosphate placebo capsules 2 times per day for 5 days
CS-8958 powder 40 mg to be inhaled one time.
Oseltamivir phosphate placebo capsules 2 times per day for 5 days
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Eksperimentel: CS-8958 High Dose
CS-8958 powder to be inhaled - high-dose arm
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CS-8958 powder 20 mg to be inhaled one time.
Oseltamivir phosphate placebo capsules 2 times per day for 5 days
CS-8958 powder 40 mg to be inhaled one time.
Oseltamivir phosphate placebo capsules 2 times per day for 5 days
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Aktiv komparator: Oseltamivir phosphate
oseltamivir phosphate oral capsules
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CS-8958 placebo powder to be inhaled one time.
Oseltamivir phosphate oral capsules taken twice daily for 5 days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to Alleviation of Influenza Illness
Tidsramme: 15 days
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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.
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15 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time for Body Temperature to Return to Normal
Tidsramme: 15 days
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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.
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15 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2008
Primær færdiggørelse (Faktiske)
1. marts 2009
Studieafslutning (Faktiske)
1. juni 2009
Datoer for studieregistrering
Først indsendt
4. december 2008
Først indsendt, der opfyldte QC-kriterier
4. december 2008
Først opslået (Skøn)
5. december 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. januar 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. december 2018
Sidst verificeret
1. november 2011
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CS8958-A-J301
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
IPD-delingstidsramme
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD-delingsadgangskriterier
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research.
This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .