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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010595
Receipt No. R000012384
Scientific Title Comparison of clinical efficacy between peramivir and oseltamivir for the treatment of influenza in high-risk patients
Date of disclosure of the study information 2013/04/26
Last modified on 2013/10/25

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Basic information
Public title Comparison of clinical efficacy between peramivir and oseltamivir for the treatment of influenza in high-risk patients
Acronym A comparative study of peramivir and oseltamivir in high-risk patients
Scientific Title Comparison of clinical efficacy between peramivir and oseltamivir for the treatment of influenza in high-risk patients
Scientific Title:Acronym A comparative study of peramivir and oseltamivir in high-risk patients
Region
Japan

Condition
Condition Influenza virus infection
Classification by specialty
Medicine in general Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the clinical efficacy between peramivir and oseltamivir for influenza virus infection in high-risk patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The duration of influenza illness
Key secondary outcomes The duration of fever, Complications

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 peramivir.
600-mg of peramivir once a day, are administered intravenously over a period of 15 to 60 min for 1 to 5 days as needed.
Interventions/Control_2 Oseltamivir.
75mg of oral oseltamivir twice a day for 5 consecutive days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (i) >=20 years old
(ii) Influenza rapid antigen test; positive
(iii) At least one risk factor: poorly controlled diabetes (hemoglobin A1c >=7.0%), chronic respiratory tract disease, chronic heart disease, chronic liver disease, chronic renal disease, malignancy, collagen vascular disease and current use of a drug that suppresses immune function (immunosuppressant drug or adrenocortical hormone preparation equivalent to >=10 mg/day of prednisolone)
(iv) Onset of influenza symptoms within the previous 48h
(v) At least two of the seven influenza symptoms: headache, muscle or joint pain, fever or chills, fatigue, cough, sore throat, and nasal congestion
Key exclusion criteria (i) Chronic respiratory failure requiring artificial ventilation
(ii) Diabetes with an HbA1c value of >=10%
(iii) Organ transplant or hematopoietic stem cell transplant within the previous 12 months
(iv) Requirement for dialysis or presence of nephropathy (estimated creatinine clearance, <50 ml/min)
(v) Presence of a complicating infection judged to require treatment by systemic administration of an antimicrobial agent
(vi) Contraindication of peramivir and oseltamivir
(vii) Pregnant women
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takafumi Suda
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, 431-3192
TEL 053-435-2111
Email suda@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taisuke Akamatsu
Organization Hamamatsu University School of Medicine
Division name Second Division, Department of Internal Medicine
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, 431-3192
TEL 053-435-2111
Homepage URL
Email redasthma@yahoo.co.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 04 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 01 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 04 Month 25 Day
Last modified on
2013 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012384

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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