UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038923 |
|---|---|
| Receipt number | R000044376 |
| Scientific Title | The Survey of orofacial pain in Japan. |
| Date of disclosure of the study information | 2019/12/18 |
| Last modified on | 2019/12/18 14:39:58 |
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Basic information
Public title
The Survey of orofacial pain in Japan.
Acronym
The Survey of orofacial pain in Japan.
Scientific Title
The Survey of orofacial pain in Japan.
Scientific Title:Acronym
The Survey of orofacial pain in Japan.
Region
| Japan |
Condition
Condition
Orofacial Pain
Classification by specialty
| Neurology | Psychosomatic Internal Medicine | Orthopedics |
| Anesthesiology | Oral surgery | Neurosurgery |
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To survey the actual status of orofacial pain
2)To evaluate the characters of orofacial pain patients
Basic objectives2
Others
Basic objectives -Others
To evaluate the characters of orofacial pain in general population.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary,: Location and degree of pain, prevalence of OFP
Secondary: duration of suffering, source of pain, medical histories, phycho^social actors, QoL, Social and economical loss.
Key secondary outcomes
To evaluate the affective factors of OFP
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)the citizens registrated Rakten Insight Co.
(2)the registrators who understand and agree to attend this study.
Key exclusion criteria
(1) the registrations decided they were not suitable for this study
Target sample size
400000
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyushu University Faculty of Dental Science
Division name
Department of Dental Anesthesiology
Zip code
8128583
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL
092-642-6478
esakamto@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyushu University Faculty of Dental Science
Division name
Department of Dental Anesthesiology
Zip code
8128583
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
TEL
092-642-6478
Homepage URL
esakamto@dent.kyushu-u.ac.jp
Sponsor or person
Institute
Committee of clinical investigation of Japanese Society of Orofacial Pain
Institute
Department
Personal name
Funding Source
Organization
Committee of the clinical investigation of Japanese Society of Orofacial Pain
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Committee of clinical investigation of Japanese Society of Orofacial Pain
Address
Maidashi 3-1-1 Higashiku Fukuoka, Fukuoka JAPAN
Tel
092^642-6478
esakamto@dent.kyushu-u.ac.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
| 2019 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36000
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
| 2019 | Year | 03 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data from 36000 general population in Japan is analyzing.
Management information
Registered date
| 2019 | Year | 12 | Month | 18 | Day |
Last modified on
| 2019 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044376
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
