UMIN-CTR Clinical Trial

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
Email	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
Email	joudannz@yahoo.co.jp

Sponsor
Institute	Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051432