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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001653
Receipt No. R000001994
Scientific Title A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.
Date of disclosure of the study information 2009/01/23
Last modified on 2010/03/26

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Basic information
Public title A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.
Acronym Exploratory evaluation of the efficacy and safety of Mao-to in the treatment of influenza.
Scientific Title A non-blind, randomized, parallel group comparative trial to study the efficacy and safety of Mao-to in the treatment of influenza.
Scientific Title:Acronym Exploratory evaluation of the efficacy and safety of Mao-to in the treatment of influenza.
Region
Japan

Condition
Condition Influenza Type A and Type B
Classification by specialty
Pneumology Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of Mao-to in the treatment of influenza by comparing residual virus, influenza symptoms and cytokine levels over time with well established antiviral agents.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes 1.Viral tests
(1) Residual virus
"Nasal swab" will be taken on Day 1, 3, and 5 (or discontinuation date) to conduct the following tests: (If sinuses are too dry for sample collection, throat swabs may be substituted. Day 6 samples will be accepted if subjects are not available or if a holiday coincides with Day 5.)
* Viral isolation and identification (PCR)
* Rapid diagnostic test for influenza (Day 3, Day 5 (or discontinuation date))
2. Influenza symptoms
(1) Time of fever clearance
Instruct subjects to record their body temperature from the start date of administration (Day 1) to Day 5. Fever clearance time is measured as the time from drug administration until the reduction of body temperature below 37.5C. (If the temperature relapses above 37.5C, fever clearance time will be considered as the last time it took for the body temperature to drop below 37.5C).
(2) Other symptoms
Instruct subjects to keep a symptom diary from the start date of administration (Day 1) until Day 5 (or discontinuation date):
* nasal discharge, nasal obstruction, sore throat, muscle ache, joint pain, malaise or fatigue, and headache.
3) Blood count, CRP and cytokine
(1) Changes in cytokine levels
Determine the blood count (WBC fraction), CRP, cytokine (IL-1, IL-6, IL-8, IL-10, TNF-a, IFNa2) levels in the blood from the start date (Day 1, prior to test drug administration), Day 3, and Day 5 (or discontinuation date).
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Test drug: Tsumura Mao-to extract granule for prescription
Normal adult dose: 7.5g PO divided BID/TID before or between meals.
Duration of administration: 5 days
Interventions/Control_2 Test drug: oseltamivir phosphate (product name: Tamiflu capsule 75)
Standard dosage for adults and children with body weight of > 37.5kg: 1 cap (75mg) PO BID x 5 days.
Interventions/Control_3 Zanamivir (product name: Relenza)
Standard dosage for adults and children: 10mg (5mg blisters of powders x 2) BID x 5 days on a ROTADISK® for oral inhalation via DISKHALER®.
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 1) Positive rapid diagnostic test for influenza.
2) Fever >= 38.0C upon admission, or fever >= 37.5C upon admission with a history of fever >= 38.0C within 4 hours prior to admission.
3) Within 48 hours after onset of influenza symptoms.
4) Age: between 20-65 yrs (at the time of signing informed consent)
5) Gender: unspecified
6) Consultation method: outpatient
7) Provision of a signed informed consent.
Key exclusion criteria 1) Administration of Kampo medicine or any respiratory medication within 3 days prior to registration.
2) Administration of influenza vaccination within 2 weeks prior to registration.
3) Serious disease complication including, but not limited to: liver, kidney, heart, lung, circulatory, or metabolic disorder.
4) Suspicion of supervening bacterial infection of the respiratory tract.
5) History of drug allergies.
6) Females who are pregnant, lactating or planning pregnancy.
7) Administration of another investigational drug within 4 weeks prior to registration or during the study period, or planned participation in another study.
8) Contraindications to acetaminophen (peptic ulcer, aspirin-induced asthma, acetaminophen hypersensitivity).
9) Subjects who are unfit for the study as judged by the research director, research staff, or others (referred to as "research director and team")
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Nabeshima
Organization Fukuoka University Hospital
Division name General medicine
Zip code
Address 45-1 7-chome Nanakuma Jonan-ku, Fukuokashi Fukuoka-ken 814-0180
TEL 092-801-1011
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Fukuoka University Hospital
Division name General medicine
Zip code
Address 45-1 7-chome Nanakuma Jonan-ku, Fukuokashi Fukuoka-ken 814-0180
TEL 092-801-1011
Homepage URL
Email

Sponsor
Institute Fukuoka University Hospital
Institute
Department

Funding Source
Organization Tsumura & Co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2009 Year 01 Month 23 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
2008 Year 12 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 01 Month 01 Day
Last follow-up date
2009 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 01 Month 23 Day
Last modified on
2010 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001994

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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