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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016883
Receipt No. R000019283
Scientific Title Regional cerebral blood flow and metabolic changes associated with brain dysfunction induced by antihistamines
Date of disclosure of the study information 2015/03/23
Last modified on 2019/04/02

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Basic information
Public title Regional cerebral blood flow and metabolic changes associated with brain dysfunction induced by antihistamines
Acronym Cerebral blood flow and metabolic changes associated with antihistamines
Scientific Title Regional cerebral blood flow and metabolic changes associated with brain dysfunction induced by antihistamines
Scientific Title:Acronym Cerebral blood flow and metabolic changes associated with antihistamines
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 evaluate the impairment in cognitive tasks after oral administration of levocetirizine 5 mg and diphenhydramine 50mg, as an active placebo, in healthy volunteers. In addition, regional cerebral blood flow and metabolism will be measured using near infrared spectroscopy (NIRS) and positron emission tomograhpy (PET).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes regional cerebral blood flow and metabolism in cognitive tests done after oral administration of levocetirizine 5 mg and diphenhydramine 50mg and placebo.
Key secondary outcomes subjective sleepiness and performance in cognitive tests done after oral administration of levocetirizine 5 mg and diphenhydramine 50mg and placebo.

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 levocetirizine 5mg
Interventions/Control_2 diphenhydramine 50mg
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 (men; young subgroup ranging 20-25 years old) who understand the purpose of this study well.
2) Healthy volunteers with his/her own will and without any subordinate relation.
3) Subjects who can take enough sleep and rest during the night before the clinical test.
4) Subjects who can contact by mobile phones and who can participate 3 serial clinical tests.
Key exclusion criteria Subjects with the following conditions are to be excluded:
1) Subjects who take medication acting on histaminergic nervous systems including antihistamines
2) Subjects with past history of severe epilepsy and allergic reactions
3) Subjects with past history of frequent hospitalization.
4) Subjects with moderate to severe glaucoma and uninary tract obstruction such as prostatic enlargement
5) Subjects with other disorders to which administration of anticholinergic and antihistaminergic treatment is not suitable
6) Subjects with moderate to severe abnormality in renal and liver functions
7) Subjects with moderate to severe cognitive impairment
8) Subjects with abnormality in brain MRI images.
9) other abnormalities, the investigators think the inclusion to this study is not suitable
Target sample size 26

Research contact person
Name of lead principal investigator
1st name Manabu
Middle name
Last name TASHIRO
Organization Tohoku University Cyclotron and Radioisotope Center/Tohoku University Graduate School of Medicine
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
Email mtashiro@m.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
Email mtashiro@m.tohoku.ac.jp

Sponsor
Institute Tohoku University Cyclotron and Radioisotope Center
Institute
Department

Funding Source
Organization GSK Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Tohoku University Graduate School of Medicine, Department of Pharmacology
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics comittee of Tohoku University Graduate School of Medicine
Address 1-1 Seiryo-cho Aoba-ku Sendai-shi Japan
Tel 022-717-8007
Email med-kenkyo@grp.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
2015 Year 03 Month 23 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 42
Results
Healthy young Japanese men received single doses of levocetirizine or diphenhydramine. Subjective feeling, task performances, and brain activity were evaluated during cognitive tests. Regional cerebral glucose consumption changes and hemodynamic responses were measured using [18F]FDG-PET and NIRS, respectively. Energy consumption in the brain was significantly increased after antihistamine administration. Stroop test accuracy was significantly impaired by diphenhydramine. 
Results date posted
2019 Year 04 Month 02 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2018 Year 03 Month 13 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 02 Month 16 Day
Date of IRB
2014 Year 10 Month 27 Day
Anticipated trial start date
2015 Year 03 Month 23 Day
Last follow-up date
2018 Year 12 Month 21 Day
Date of closure to data entry
2018 Year 12 Month 21 Day
Date trial data considered complete
2019 Year 03 Month 15 Day
Date analysis concluded
2019 Year 03 Month 20 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 23 Day
Last modified on
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019283

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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