UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002662 |
|---|---|
| Receipt number | R000003234 |
| Scientific Title | Interindividual variation of perception threshold -Examination with Neurometer® |
| Date of disclosure of the study information | 2009/10/23 |
| Last modified on | 2010/10/23 22:40:08 |
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Basic information
Public title
Interindividual variation of perception threshold -Examination with Neurometer®
Acronym
Interindividual variation of perception threshold
Scientific Title
Interindividual variation of perception threshold -Examination with Neurometer®
Scientific Title:Acronym
Interindividual variation of perception threshold
Region
| Japan |
Condition
Condition
pain
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Psychosomatic Internal Medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the distribution of perception threshold about young, healthy Japanese, and to examine the effect of NSAID to percption threshold.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
CPT value
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
Loxoprofen oral dosing
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy, young Japanese
Key exclusion criteria
recent participation to other clinical trial
history of any drug allergy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Dr. Hiromitsu Imai |
Organization
Oita university, Faculty of medicine
Division name
Dept of clinical pharmacology and therapeutics
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dr. Hiromitsu Imai |
Organization
Oita university, Faculty of medicine
Division name
Dept of clinical pharmacology
Zip code
Address
1-1 Idaigaoka Hasama Yufu-city, Oita, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Dept of clinical pharmacology and therapeutics, Oita university, Faculty of medicine
Institute
Department
Personal name
Funding Source
Organization
Dept of clinical pharmacology and therapeutics, Oita university, Faculty of medicine
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
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
| 2009 | Year | 10 | Month | 23 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 23 | Day |
Last modified on
| 2010 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003234
