UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004903 |
|---|---|
| Receipt number | R000005839 |
| Scientific Title | A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir Hydrate in Influenza Virus Infection |
| Date of disclosure of the study information | 2011/01/19 |
| Last modified on | 2022/07/29 16:26:49 |
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Basic information
Public title
A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir Hydrate in Influenza Virus Infection
Acronym
A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir
Scientific Title
A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir Hydrate in Influenza Virus Infection
Scientific Title:Acronym
A Randomized Controlled Comparative Trial of Long-Acting Neuraminidase Inhibitor Laminavir Octanoate versus Zanamivir
Region
| Japan |
Condition
Condition
adult patients with influenza virus infection
Classification by specialty
| Medicine in general | Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conduct a randomized controlled trial to compare the efficacy and safety of long-acting neuraminidase inhibitor laninamivir octanoate vs zanamivir hydrate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the time to alleviation of influenza illness, which was defined as the interval between the start of the trial treatment and the start of the first 24 hour period in which influenza symptoms have improved to absent or mild
Key secondary outcomes
the time to alleviation of influenza illness, which was defined as the interval between the start of the trial treatment and the start of the first 24 hour period in which axillary temperatures have returned to 36.9 celsius degree
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
NO
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
long-acting neuraminidase inhibitor laninamivir octanoate treatment group
Interventions/Control_2
zanamivir hydrate treatment group
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Eligible patients are as follows;
- patients who are diagnosed as influenza virus (A or B) infection using a rapid diagnostic kit
- patients who have axillary temperatures of 37.5 celsius degree or higher measured at clinic
- patients who present within 48 hours of the onset of influenza symptoms
- patients who provide written informed consent
- age: 20-65 old
- patients who can use inhaling devices
Key exclusion criteria
Patients are to be excluded from the trial;
- if they reported influenza symptoms and had been treated with any antibiotics or antivirus medications within 1 week before enrollment,
- if they had any chronic respiratory disease (bronchial asthma, chronic obstructive pulmonary disease)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tadanori |
| Middle name | |
| Last name | SASAKI |
Organization
Kameda Clinic
Division name
Pharmacy Department
Zip code
296-8062
Address
1344 Higashi-cho, Kamogawa-city, Chiba, Japan
TEL
04-7099-2211
sasaki.tadanori@kameda.jp
Public contact
Name of contact person
| 1st name | Tadanori |
| Middle name | |
| Last name | SASAKI |
Organization
Kameda Medical Center
Division name
Pharmacy Department
Zip code
296-0041
Address
929 Higashi-cho, Kamogawa-city, Chiba, Japan
TEL
04-7092-2211
Homepage URL
Sasaki.tadanori@kameda.jp
Sponsor or person
Institute
Kameda Clinic
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kameda Medical Center
Address
Higashi-cho 1344, Kamogawa Chiba
Tel
04-7099-2211
sasaki.tadanori@kameda.jp
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
| 2011 | Year | 01 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2011 | Year | 01 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005839
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
