UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006848 |
|---|---|
| Receipt number | R000007560 |
| Scientific Title | Local pharmacologic MRA with nitroglycerin skin spray |
| Date of disclosure of the study information | 2011/12/06 |
| Last modified on | 2019/04/24 14:03:46 |
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Basic information
Public title
Local pharmacologic MRA with nitroglycerin skin spray
Acronym
Local pharmacologic MRA with nitroglycerin
Scientific Title
Local pharmacologic MRA with nitroglycerin skin spray
Scientific Title:Acronym
Local pharmacologic MRA with nitroglycerin
Region
| Japan |
Condition
Condition
healthy volunteers
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pilot study of non-enhanced MRA with nitroglycerin skin spray using upper extremities of healthy volunteers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
We will compare the visibility of MRA using nitroglycerin skin spray in upper extremities using 5 score scale among three different groups of healthy volunteers: i.e. non-spray group, ipsilateral spray group and contralateral spray group, and confirm the usefulness of the nitroglycerin skin spray on pharmacologic MRA of upper extremities.
Key secondary outcomes
We will evaluate side effects after spraying nitroglycerin.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
non-spray and nitroglycerin skin spray on ipsilateral brachail artery
Interventions/Control_2
non-spray and nitroglycerin skin spray on contralateral brachail artery
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
healthy adults
Key exclusion criteria
coronary vessel disease
pregnant
renal dysfunction
during the administration of drugs
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keizo Tanitame |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keizo Tanitame |
Organization
Hiroshima University
Division name
Department of Diagnostic Radiology
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department of Diagnostic Radiology, Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Department of Diagnostic Radiology, Hiroshima University
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
| 2011 | Year | 12 | Month | 06 | 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
| 2011 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007560
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| Registered date | File name |
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| Registered date | File name |
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