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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000000924
Receipt No. R000001112
Scientific Title A retrospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing major abdominal surgery
Date of disclosure of the study information 2007/12/03
Last modified on 2015/06/03

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Basic information
Public title A retrospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing major abdominal surgery
Acronym A study on gene polymorphism effects on postoperative pain management
Scientific Title A retrospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing major abdominal surgery
Scientific Title:Acronym A study on gene polymorphism effects on postoperative pain management
Region
Japan

Condition
Condition Pain
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To develop a way of personalized pain treatment by examining associations between gene polymorphisms and postoperative opioid requirements or intensity of postoperative pain in patients undergoing major abdominal surgery
Basic objectives2 Others
Basic objectives -Others Sensitivity to analgesics
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Associations between gene polymorphisms and postoperative opioid requirements or intensity of postoperative pain in patients who had undergone major abdominal surgery in the last several years
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
75 years-old >
Gender Male and Female
Key inclusion criteria Patients who had undergone major abdominal surgery in the last several years and who agreed to participate in the study with written informed consent
Key exclusion criteria Patients less than 20 years and more than 75 years or those with severe complications
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazutaka Ikeda
Organization Tokyo Metropolitan Institute of Medical Science
Division name Addictive Substance Project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL 03-6834-2379(EXT-3825)
Email ikeda-kz@igakuken.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Ikeda
Organization Tokyo Metropolitan Institute of Medical Science
Division name Addictive Substance Project
Zip code
Address 2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
TEL 03-6834-2379(EXT-3825)
Homepage URL
Email ikeda-kz@igakuken.or.jp

Sponsor
Institute Tokyo Metropolitan Institute of Medical Science
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor The University of Tokyo, The Institute of Medical Science
Toho University Sakura Medical Center
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 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.igakuken.or.jp/abuse/publications.html
Number of participants that the trial has enrolled
Results
American Society of Human Genetics (ASHG) 57th Annual Meeting
Japanese Society of Clinical Neuropsychopharmacology (JSCNP) 19th Annual Meeting / Japanese Society of Neuropsychopharmacology (JSNP) 39th Annual Meeting
American Society of Human Genetics (ASHG) 60th Annual Meeting
Japanese Society of Clinical Neuropsychopharmacology (JSCNP) 20th Annual Meeting / Japanese Society of Neuropsychopharmacology (JSNP) 40th Annual Meeting
Japanese Society of Clinical Neuropsychopharmacology (JSCNP) 22th Annual Meeting / Japanese Society of Neuropsychopharmacology (JSNP) 42th Annual Meeting
European Human Genetics Conference 2013
XXIst World Congress of Psychiatric Genetics

Method of evaluating drug-sensitivity by analyzing the mu-opioid receptor gene
Method of evaluating drug-sensitivity by analyzing the GIRK channel genes

Hayashida M, Nagashima M, Satoh Y, Katoh R, Tagami M, Ide S, Kasai S, Nishizawa D, Ogai Y, Hasegawa J, Komatsu H, Sora I, Fukuda K, Koga H, Hanaoka K, Ikeda K.
Analgesic requirements after major abdominal surgery are associated with OPRM1 gene polymorphism genotype and haplotype.
Pharmacogenomics. 2008 Nov;9(11):1605-16.

Nishizawa D, Nagashima M, Katoh R, Satoh Y, Tagami M, Kasai S, Ogai Y, Han W, Hasegawa J, Shimoyama N, Sora I, Hayashida M, Ikeda K.
Association between KCNJ6 (GIRK2) gene polymorphisms and postoperative analgesic requirements after major abdominal surgery.
PLoS One. 2009 Sep 16;4(9):e7060.

Nishizawa D, Fukuda K, Kasai S, Hasegawa J, Aoki Y, Nishi A, Saita N, Koukita Y, Nagashima M, Katoh R, Satoh Y, Tagami M, Higuchi S, Ujike H, Ozaki N, Inada T, Iwata N, Sora I, Iyo M, Kondo N, Won MJ, Naruse N, Uehara-Aoyama K, Itokawa M, Koga M, Arinami T, Kaneko Y, Hayashida M, Ikeda K.
Genome-wide association study identifies a potent locus associated with human opioid sensitivity.
Mol Psychiatry. 2014 Jan;19(1):55-62. doi: 10.1038/mp.2012.164. Epub 2012 Nov 27.

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 Open public recruiting
Date of protocol fixation
2003 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 01 Month 01 Day
Last follow-up date
2015 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A retrospective study examining associations between gene polymorphisms and postoperative opioid requirements or intensity of postoperative pain using patient samples

Management information
Registered date
2007 Year 12 Month 03 Day
Last modified on
2015 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001112

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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