UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045028 |
|---|---|
| Receipt number | R000051432 |
| Scientific Title | Effects of polymorphisms in the serotonin transporter promoter-linked polymorphic region on on pain severity and quality of life in patients with herpetic neuralgia- a cross sectional study |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2021/07/31 22:58:11 |
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Basic information
Public title
Effects of polymorphisms in the serotonin transporter promoter-linked polymorphic region on on pain severity and quality of life in patients with herpetic neuralgia- a cross sectional study
Acronym
Effects of polymorphisms in the serotonin transporter promoter-linked polymorphic region on on pain severity and quality of life in patients with herpetic neuralgia- a cross sectional study
Scientific Title
Effects of polymorphisms in the serotonin transporter promoter-linked polymorphic region on on pain severity and quality of life in patients with herpetic neuralgia- a cross sectional study
Scientific Title:Acronym
Effects of polymorphisms in the serotonin transporter promoter-linked polymorphic region on on pain severity and quality of life in patients with herpetic neuralgia- a cross sectional study
Region
| Japan |
Condition
Condition
postherpetic neuralgia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To observe the effect of 5-HTTLPR on pain severity and quality of life in patients with postherpetic neuralgia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pain scale, quality of life
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
postherpetic neuralgia
Key exclusion criteria
none
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamasaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahi-machi Abeno-ku Osaka city Japan
TEL
0666452186
joudannz@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yamasaki |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
5458586
Address
1-5-7 Asahi-machi Abeno-ku Osaka city Japan
TEL
0666452186
Homepage URL
joudannz@yahoo.co.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University Graduate School of Medicine
Address
1-5-7 Asahi-machi Abeno-ku Osaka city Japan
Tel
0666453456
ethics@med.osaka-cu.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
| 2021 | Year | 07 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Pain scale, evaluation of quality of life, effect of treatment
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051432
