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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000612
Receipt No. R000000742
Scientific Title Preliminary study of close monitoring for outpatients of spring hay fever using newly invented support system, Rtime.
Date of disclosure of the study information 2007/07/17
Last modified on 2008/02/19

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Basic information
Public title Preliminary study of close monitoring for outpatients of spring hay fever using newly invented support system, Rtime.
Acronym Preliminary study for patient close monitoring system
Scientific Title Preliminary study of close monitoring for outpatients of spring hay fever using newly invented support system, Rtime.
Scientific Title:Acronym Preliminary study for patient close monitoring system
Region
Japan

Condition
Condition spring hay fever
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 system validation of Rtime for H1-antagonist treatment outcomes of outpatients hay fever
Basic objectives2 Others
Basic objectives -Others validation for support system
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes global assessment of Rtime operationality
Key secondary outcomes drug compliance, follow rate, sleepness score, global assessment of symptom, consent rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria who can participate with written consent, who is applicable for H1-antagonist treatment, who has spring hay fever, who is outpatient.
Key exclusion criteria who is not apllicable for H1 antagonist, who may need systemin steroid treatment, who plans to apply hyposensitization therapy or surgical procedures at the time of consent, who is under the medication which affects to daytime sleepness.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name ISAMU HORIKAWA
Organization Horikawa Clinic
Division name otorhinolaryngology
Zip code
Address 270 Okyozuka, Nonoichi , ISHIKAWA
TEL 076-240-0600
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Oita University
Division name Clinical Pharmacology Center
Zip code
Address
TEL
Homepage URL http://www.med.oita-u.ac.jp/clinical_pharmacology/souyaku/
Email

Sponsor
Institute Oita University
Institute
Department

Funding Source
Organization NPO HEART
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
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
2007 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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
2007 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 01 Day
Last follow-up date
2007 Year 07 Month 01 Day
Date of closure to data entry
2007 Year 07 Month 01 Day
Date trial data considered complete
2007 Year 08 Month 01 Day
Date analysis concluded
2007 Year 09 Month 01 Day

Other
Other related information open to public at any meetings

Management information
Registered date
2007 Year 02 Month 19 Day
Last modified on
2008 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000742

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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