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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034519
Receipt No. 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 2018/11/13

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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
Middle name
Last name Shigeki Yamaguchi
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Email shigeki@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Takasusuki
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2018 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 16 Day
Last follow-up date
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
2018 Year 11 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039360

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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