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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030716
Receipt No. R000035068
Scientific Title Examination of the sensory threshold in patients with opioid treatment
Date of disclosure of the study information 2018/01/07
Last modified on 2018/01/07

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Basic information
Public title Examination of the sensory threshold in patients with opioid treatment
Acronym Sensory threshold in opioid use
Scientific Title Examination of the sensory threshold in patients with opioid treatment
Scientific Title:Acronym Sensory threshold in opioid use
Region
Japan

Condition
Condition Cancer pain
Classification by specialty
Hematology and clinical oncology Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the effect of opioid use on the sensory function in patines with cancer pain
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sensory threthold, pain threshold
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
Device,equipment
Interventions/Control_1 We evaluate sensory threthold using Sensory Nerve Testing Equipment(Neurometer) providing current on patient's skin
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1.more or equal 20years, belw 90years
2.more or equal 4 of Numerical Rating Scale
Key exclusion criteria 1.Skin diseases at test skin
2.History of serious allergy
3.Severe noncnacer pain
4.Sensory disturbance
5.Diabetes
6.Serious heart diseases and lung diseases
7.Consciousness disturbance, Dementia, Mental disorder
8.Aphasia, Auditory disturbance, Dysopia
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akifumi Kanai
Organization Kitasato University Hospital
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL 042-778-8111
Email kanaiakifumi@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Akifumi Kanai
Organization Kitasato University Hospital
Division name Anesthesiology
Zip code
Address 1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL 042-778-8111
Homepage URL
Email kanaiakifumi@aol.com

Sponsor
Institute Kitasato University Hospital
Institute
Department

Funding Source
Organization Department of Anesthesiology, Kitasato University Hospital
Organization
Division
Category of Funding Organization Self funding
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 01 Month 07 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 Preinitiation
Date of protocol fixation
2018 Year 01 Month 07 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 07 Day
Last modified on
2018 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035068

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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