UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000924 |
|---|---|
| Receipt number | 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 13:01:04 |
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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)
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
ikeda-kz@igakuken.or.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001112
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
