UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016883 |
|---|---|
| Receipt number | 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 20:20:15 |
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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
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
mtashiro@m.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Cyclotron and Radioisotope Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019283
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