UMIN-CTR Clinical Trial

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
Email	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
Email	Sasaki.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	Kameda Medical Center
Address	Higashi-cho 1344, Kamogawa Chiba
Tel	04-7099-2211
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000005839