UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034519 |
|---|---|
| Receipt number | R000039360 |
| Scientific Title | Effects of methadone on cardiac repolarization in cancer patients. |
| Date of disclosure of the study information | 2018/10/16 |
| Last modified on | 2021/07/19 12:21:42 |
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Basic information
Public title
Effects of methadone on cardiac repolarization in cancer patients.
Acronym
Methadone and cardiac repolarization
Scientific Title
Effects of methadone on cardiac repolarization in cancer patients.
Scientific Title:Acronym
Methadone and cardiac repolarization
Region
| Japan |
Condition
Condition
Cancer pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We sought to assess the effect of methadone on QT dispersion(QTD), T peak-T end(TpTe), TpTe/QT and TpTe/QTc in cancer patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We will evaluate the influence of methadone on QTD, TpTe, TpTe/QT and TpTe/QTc before, 1, 3, 6 months after administration.
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
The cancer patients aged 20-75 years who were prescribed methadone will be enrolled.
Key exclusion criteria
The patients with cardiovascular desease and ECG abnormalities will be excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
shigeki@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshifumi |
| Middle name | |
| Last name | Takasusuki |
Organization
Dokkyo Medical University
Division name
Department of Anesthesiology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-86-1111
Homepage URL
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
Tel
+81282861111
takasusu@dokkyomed.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
| 2018 | Year | 10 | Month | 16 | 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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate the QTD, TpTe, TpTe/QT and TpTe/QTc before, 0,1,3,6 months after administration of methadone for cancer pain.
Management information
Registered date
| 2018 | Year | 10 | Month | 16 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039360
| 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 |
