UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000925 |
|---|---|
| Receipt number | R000001113 |
| Scientific Title | A prospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing orthognathic surgery |
| Date of disclosure of the study information | 2007/12/03 |
| Last modified on | 2024/12/16 11:44:23 |
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Basic information
Public title
A prospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing orthognathic surgery
Acronym
A study on gene polymorphism effects on postoperative pain management
Scientific Title
A prospective study on the effects of gene polymorphisms on postoperative pain management in patients undergoing orthognathic 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
Others
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 orthognathic 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 during 24 hours after surgery
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
| 15 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo orthognathic surgery and agree to participate in the study with written informed consent
Key exclusion criteria
Patients less than 15 years and more than 60 years or those with severe complications
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
156-8506
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 | Kazutaka |
| Middle name | |
| Last name | Ikeda |
Organization
Tokyo Metropolitan Institute of Medical Science
Division name
Addictive Substance Project
Zip code
156-8506
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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Tokyo Dental College Suidobashi Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Ethics Committee, Tokyo Metropolitan Institute of Medical Science
Address
2-1-6 Kamikitazawa, Setagaya-ku, Tokyo
Tel
03-6834-2391
renkei@igakuken.or.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
| 2007 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
http://www.igakuken.or.jp/abuse/publications.html
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
400
Results
Method of evaluating drug-sensitivity by analyzing the voltage-dependent Ca2+ channel gene
Method of evaluating drug-sensitivity by analyzing the adrenergic receptor genes
Method of evaluating drug-sensitivity and vulnerability to diseases by analyzing the cyclic-AMP response element-binding protein gene
Method of evaluating drug-sensitivity by analyzing several genes related to analgesia
Nishizawa et al.
Mol Psychiatry. 2014 Jan;19(1):55-62. doi: 10.1038/mp.2012.164. Epub 2012 Nov 27.
Results date posted
| 2024 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Surgical patients aged 15-60 years undergoing mandibular osteotomy at Suidobashi Hospital, Tokyo Dental College
Participant flow
Participants will fill out a consent form to participate in the study at the hospital, provide oral mucosa or peripheral blood, and undergo mandibular osteotomy.
Adverse events
None
Outcome measures
Analgesics and pain sensitivity
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2004 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2005 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A 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
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001113
