UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007383 |
|---|---|
| Receipt number | R000008541 |
| Scientific Title | Brain histamine H1 receptor occupancy of newly-marketed non-sedating antihistamines: PET measurement in normal volunteers |
| Date of disclosure of the study information | 2012/02/27 |
| Last modified on | 2015/04/20 14:25:17 |
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Basic information
Public title
Brain histamine H1 receptor occupancy of newly-marketed non-sedating antihistamines: PET measurement in normal volunteers
Acronym
Histamine H1 receptor occupancy of antihistamines
Scientific Title
Brain histamine H1 receptor occupancy of newly-marketed non-sedating antihistamines: PET measurement in normal volunteers
Scientific Title:Acronym
Histamine H1 receptor occupancy of antihistamines
Region
| Japan |
Condition
Condition
Normal 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, and positron emission tomography (PET) measurement of H1 receptor occupancy. This study is designed to evaluate brain histamine H1 receptor occupancy using carbon-11 doxepin after oral administration of levocetirizine 5 mg and fexofenadine 60 mg in normal volunteers.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Brain histamine H1 receptor occupancy after oral administration of levocetirizine 5 mg and fexofenadine 60 mg.
Key secondary outcomes
Subjective sleepiness scale, time course of plasma drug concentration, and brain histamine H1 receptor occupancy after oral administration of levocetirizine 5 mg, fexofenadine 60 mg, 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
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
levocetirizine 5 mg
Interventions/Control_2
fexofenadine 60 mg
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
| 30 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Normal volunteers with his own free will. There is no subordinate relation.
2. Male healthy volunteers aged 20-30 years old, who understand the purpose of this study.
3. Subjects who can take enough sleep and rest at the previous night of PET scans
4. Subjects who can read documents attached with e-mail.
5. Subjects who can communicate with mobile phones.
6. Subjects who can take 3 PET-sacns examination and 1 MRI scan.
Key exclusion criteria
1. Subjects who take no medication including antihistamines at present.
2. Subjects who do not take any PET scans within the recent 2 years.
3. No serious allergy
4. No convulsion at past
5. No frequent medical addmission
6. No glaucoma and prostatic hypertrophy
7. Subjects who can not take any anticholinergic and antihistaminergic drugs from medical points of view.
8. No brain MRI abnormality
9. Inadequate subjects from the point of medical view of the investigators.
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yanai Kazuhiko |
Organization
Tohoku University Graduate School of Medicine
Division name
Pharmacology
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 Japan
TEL
022-717-8055
yanai@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yanai Kazuhiko |
Organization
Tohoku University Graduate School of Medicine
Division name
Pharmacology
Zip code
Address
2-1 Seiryo-machi, Aoba-ku, Sendai 980-8575 Japan
TEL
022-717-8055
Homepage URL
http://www.pharmacology.med.tohoku.ac.jp/
yanai@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
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
Tokyo Metorpolitan Geriatric Hospital and Institute of Gerontology
Name of secondary funder(s)
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
東北大学大学院医学系研究科・機能薬理学
東京都健康長寿医療センター研究所・附属診療所
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 27 | 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
There was no significant difference between the mean brain histamine H1 receptor occupancy (H1RO) after levocetirizine administration and fexofenadine administration. Similarly, subjective sleepiness was not significantly different between the two antihistamines and placebo. Neither subjective sleepiness nor plasma concentrations was
significantly correlated with the brain H1RO of the two antihistamines. At therapeutic dose, levocetirizine does not bind significantly to the brain H1Rs and does not induce significant sedation.
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
| 2011 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
This study has been published in the following article. Expert Opin Drug Saf. 2015 Feb;14(2):199-206.
doi: 10.1517/14740338.2015.989831.
Management information
Registered date
| 2012 | Year | 02 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008541
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
