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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004903
Receipt No. 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 2011/01/28

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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
Middle name
Last name Tadanori SASAKI
Organization Kameda Clinic
Division name Pharmacy Department
Zip code
Address 1344 Higashi-cho, Kamogawa-city, Chiba, Japan
TEL 04-7099-2211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadanori SASAKI
Organization Kameda Medical Center
Division name Pharmacy Department
Zip code
Address 929 Higashi-cho, Kamogawa-city, Chiba, Japan
TEL 04-7092-2211
Homepage URL
Email tadanori@kameda.jp

Sponsor
Institute Kameda Clinic
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2011 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
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
2011 Year 01 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005839

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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