UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010595 |
|---|---|
| Receipt number | 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 14:45:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
redasthma@yahoo.co.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012384
