UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037806 |
|---|---|
| Receipt number | R000043077 |
| Scientific Title | Research on effect of antihistamine drugs on brain perfusion |
| Date of disclosure of the study information | 2019/08/26 |
| Last modified on | 2023/03/03 20:11:11 |
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Basic information
Public title
Research on effect of hay fever drugs on brain functions
Acronym
Effect of hay fever drugs on brain
Scientific Title
Research on effect of antihistamine drugs on brain perfusion
Scientific Title:Acronym
Antihistamines and brain perfusion
Region
| Japan |
Condition
Condition
Allergy (Healthy volunteers)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
H1 antihistamines are often used in the medication for allergic diseases, coughs and colds, and insomnia, with or without prescription, even though their sedative properties are a potentially dangerous unwanted side effect that is not properly recognized. These sedative properties have been evaluated using the incidence of subjective sleepiness, objective cognitive and psychomotor functions in a cognitive study.
This study is designed to mainly evaluate the changes in brain perfusion.
Basic objectives2
Others
Basic objectives -Others
This study aims at measuring the cebebral blood flow changes or hemodynamic changes using positron emission tomorgraphy (PET) and near infrared spectroscopy (NIRS), respectively. This measurement is done after oral administration of levocetirizine 5 mg and diphenhydramine 50mg, as an active placebo, in healthy volunteers.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
regional cerebral blood flow during cognitive tests done after oral administration of antihistamines.
Key secondary outcomes
subjective sleepiness and performance in cognitive tests done after oral administration of antihistamines.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
diphenhydramine 50mg
Interventions/Control_2
levocetirizine 5mg
Interventions/Control_3
placebo
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
| 25 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy volunteers
2) Performance Status (Grade 0)
3) ranging 20-25 years old
4) men
5) right-handed
Key exclusion criteria
1) Subjects who take medications (including antihistamines) acting on histaminergic nervous systems and other targets
2) Subjects with abnormality in brain MRI images.
3) Subjects with past history of severe allergic reactions against drugs and foods as well as against chemicals (skin allergy etc.)
4) Subjects with past history of epilepsy
5) Subjects with moderate to severe glaucoma and uninary tract obstruction such as prostatic enlargement
6) Subjects with other disorders to which administration of anticholinergic and antihistaminergic treatment is not suitable
7) Subjects with moderate to severe abnormality in renal and liver functions
8) Subjects with past experiences of taking PEET examinations within 3 years of the present study as well as with other abnormalities, the investigators think the inclusion to this study is not suitable
Target sample size
11
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku University Cyclotron and Radioisotope Center
Division name
Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Zip code
980-8578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-7797
manabu.tashiro.a2@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | TASHIRO |
Organization
Tohoku University Cyclotron and Radioisotope Center
Division name
Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Zip code
980-8578
Address
6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL
022-795-7797
Homepage URL
manabu.tashiro.a2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Cyclotron and Radioisotope Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Comittee Tohoku University Hospital
Address
1-1 Seiryo-cho Aoba-ku Sendai-shi Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.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
東北大学サイクロトロン・ラジオアイソトープセンター・サイクロトロン核医学（東北大学病院出張診療所）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 26 | 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
12
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043077
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