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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008053
Receipt No. R000009205
Scientific Title The effect of antihistamines on driving performance using a driving simulator in young and eldery persons
Date of disclosure of the study information 2012/05/29
Last modified on 2019/01/27

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Basic information
Public title The effect of antihistamines on driving performance using a driving simulator in young and eldery persons
Acronym The effect of antihistamines on driving performance in eldery persons
Scientific Title The effect of antihistamines on driving performance using a driving simulator in young and eldery persons
Scientific Title:Acronym 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
1st name
Middle name
Last name 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)
Zip code
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
1st name
Middle name
Last name Manabu TASHIRO
Organization Tohoku University Cyclotron and Radioisotope Center
Division name Division of Cyclotron Nulclear Medicine (a branch clinic of Tohoku University Hospital)
Zip code
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

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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 Completed
Date of protocol fixation
2012 Year 01 Month 23 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009205

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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