UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008053 |
|---|---|
| Receipt number | 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 17:25:47 |
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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
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
mtashiro@cyric.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)
Japan Research Foundation for Clinical Pharmacology
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009205
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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