UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of antihistamines on driving performance using a driving simulator in young and eldery persons
Title of the study (Brief title)	The effect of antihistamines on driving performance in eldery persons
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. This study is designed to evaluate the impairment in performances of simulated car-driving after oral administration of levocetirizine 5 mg and fexofenadine 60 mg, as well as diphenhydramine 50mg as an active placebo, in healthy volunteers.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase IV

Assessment
Primary outcomes	Performances in simulated car-driving tests done before and after oral administration of levocetirizine 5 mg, fexofenadine 60 mg, diphenhydramine 50mg and placebo.
Key secondary outcomes	Subjective sleepiness scale and time course of plasma drug concentration measureed before and after oral administration of levocetirizine 5 mg, fexofenadine 60 mg, diphenhydramine 50mg and placebo.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	levocetirizine 5mg
Interventions/Control_2	fexofenadine 60mg
Interventions/Control_3	diphenhydramine 50mg
Interventions/Control_4	placebo
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy volunteers with his/her own will and without any subordinate relation. 2) Healthy volunteers (men and women; young subgroup ranging 20-40 years old and elderly subgroup ranging 65-79 years old) who understand the purpose of this study well. 3) Healthy volunteers who have driving habit of at least once a week for more than 1 year. 4) Subjects who can take enough sleep and rest during the night before the clinical test. 5) Subjects who can read documents attached to e-mails. 6) Subjects who can contact by mobile phones and who can participate 4 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) Women being possiblly pregnant 3) Subjects with past history of severe epilepsy and allergic reactions 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 moderate to severe cognitive impairment 9) Subjects with other abnormalities, the investigators think the inclusion to this study is not suitable
Target sample size	40

Research contact person
Name of lead principal investigator	Manabu 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)
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	+81(0)22-795-7797
Email	mtashiro@m.tohoku.ac.jp

Public contact
Name of contact person	Manabu TASHIRO
Organization	Tohoku University Cyclotron and Radioisotope Center
Division name	Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Address	6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan
TEL	+81(0)22-795-7797
Homepage URL	http://kakuigaku.cyric.tohoku.ac.jp/pet_mame04.html
Email	mtashiro@cyric.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)	Japan Research Foundation for Clinical Pharmacology

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	2012 Year 05 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 01 Month 23 Day
Anticipated trial start date	2012 Year 05 Month 01 Day
Last follow-up date	2013 Year 12 Month 01 Day
Date of closure to data entry	2013 Year 12 Month 01 Day
Date trial data considered complete	2013 Year 12 Month 01 Day
Date analysis concluded	2014 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 05 Month 29 Day
Last modified on	2019 Year 01 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009205