UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000612 |
|---|---|
| Receipt number | 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 11:59:15 |
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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
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/
Sponsor or person
Institute
Oita University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000742
