UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003814 |
|---|---|
| Receipt number | R000004361 |
| Scientific Title | Clinical study on the effects of various single nucleotide polymorphisms on the analgesic and adverse effects of opioids |
| Date of disclosure of the study information | 2010/06/23 |
| Last modified on | 2016/12/30 09:09:02 |
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Basic information
Public title
Clinical study on the effects of various single nucleotide polymorphisms on the analgesic and adverse effects of opioids
Acronym
Genomic polymorphisms and effects of opioids
Scientific Title
Clinical study on the effects of various single nucleotide polymorphisms on the analgesic and adverse effects of opioids
Scientific Title:Acronym
Genomic polymorphisms and effects of opioids
Region
| Japan |
Condition
Condition
intraoperative and postoperative pain in patients undergoing colectomy
Classification by specialty
| Gastrointestinal surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate relationships between genomic polymorphisms and analgesic as well as adverse effects of opioids in patients undergoing laparoscopic colectomy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
analgesic effects of fentanyl eveluated by pain test, amount of remifentanil required intraoperatively, amount of fentanyl required posoperatively, postoperative pain scale, adverse effects of fentanyl, genome-wide analysis of genomic polymorphisms
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
evaluation of analgesic effects of fentanyl using electricity-induced pain test
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 undergoing laparoscopic colectomy
Key exclusion criteria
patients with serious co-existing disease, patients taking tranquilizers or analgesics
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayashida, Masakazu |
Organization
Saitama Medical University International Medical Center
Division name
Department of Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama 350-1298, Japan
TEL
042-984-4394
mhaya@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayashida, Masakazu |
Organization
Saitama Medical University International Medical Center
Division name
Department of Anesthesiology
Zip code
Address
1397-1 Yamane, Hidaka-shi, Saitama, Japan
TEL
042-984-4394
Homepage URL
hayashi4@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
埼玉医科大学国際医療センター
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.juntendo.ac.jp/graduate/kenkyudb/search/achievement.php?MID=4664
Number of participants that the trial has enrolled
Results
We have identified multiple single nucleotide polymorhisms that can srtrongly affect postoperative fentanyl requirements by performing genome-wide association study in 350 patients who underwent laparoscopic colectomy.
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
Completed
Date of protocol fixation
| 2010 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 23 | Day |
Last modified on
| 2016 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004361
| Research Plan | |
|---|---|
| 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 |
