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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Allergy (Healthy volunteers) | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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 |
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Target sample size | 26 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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. | ||||||
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Recruitment status | Completed | ||||||
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Last modified on |
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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 | |
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