UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047862 |
|---|---|
| Receipt number | R000054567 |
| Scientific Title | Elucidation of the relationship between methadone blood concentration and CYP2B6 genetic polymorphism and long QT |
| Date of disclosure of the study information | 2022/05/25 |
| Last modified on | 2023/05/26 10:34:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Elucidation of the relationship between methadone blood concentration and CYP2B6 genetic polymorphism and long QT
Acronym
Elucidation of the relationship between methadone blood concentration and CYP2B6 genetic polymorphism and long QT
Scientific Title
Elucidation of the relationship between methadone blood concentration and CYP2B6 genetic polymorphism and long QT
Scientific Title:Acronym
Elucidation of the relationship between methadone blood concentration and CYP2B6 genetic polymorphism and long QT
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the relationship between methadone blood concentration and long QT and the involvement of CYP2B6 genetic polymorphism in Japanese
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
methadone blood concentration, QT interval, CYP2B6 phenotype
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
Patients scheduled to receive methadone for cancer pain and admitted to Tohoku Medical and Pharmaceutical University Hospital
Key exclusion criteria
Pregnant women or patients who may be pregnant, Lactating patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | KAORI |
| Middle name | |
| Last name | KOYAMA |
Organization
Tohoku Medical and Pharmaceutical University Hospital
Division name
Department of Supportive Medicine and Care for Cancer
Zip code
983-8512
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL
022-259-1221
kaori0217@hosp.tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | RYUSUKE |
| Middle name | |
| Last name | OUCHI |
Organization
Tohoku Medical and Pharmaceutical University
Division name
Division of Clinical Pharmaceutics and Pharmacy Practice
Zip code
983-8536
Address
1-15-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
TEL
022-290-8850
Homepage URL
rouchi@tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Pharmaceutical Palliative Care and Sciences
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
Tohoku Medical and Pharmaceutical University Hospital
Address
1-12-1 Fukumuro, Miyagino-ku, Sendai, Miyagi
Tel
022-259-1221
research@hosp.tohoku-mpu.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
| 2022 | Year | 05 | Month | 25 | 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
| 2022 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2022 | Year | 05 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054567
