UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011372
Receipt No. R000013278
Scientific Title Brain histamine H1 receptor occupancy of sedating OTC antihistamines: Time-course of receptor occupancy measured by PET in normal volunteers
Date of disclosure of the study information 2013/08/05
Last modified on 2017/10/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Brain histamine H1 receptor occupancy of sedating OTC antihistamines: Time-course of receptor occupancy measured by PET in normal volunteers
Acronym Histamine H1 receptor occupancy of OTC antihistamines
Scientific Title Brain histamine H1 receptor occupancy of sedating OTC antihistamines: Time-course of receptor occupancy measured by PET in normal volunteers
Scientific Title:Acronym Histamine H1 receptor occupancy of OTC antihistamines
Region
Japan

Condition
Condition Normal volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Sedating H1 antihistamines are often used in the medication for allergic diseases, coughs and colds, and insomnia, 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 sequentially using carbon-11 doxepin after oral administration of OTC antihistamines containing ketotifen 1.38 mg and diphenhydramine 50 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 3 and 23 hours after oral administration of ketotifen 1.38 mg and diphenhydramine 50 mg.
Key secondary outcomes Subjective sleepiness scale 3 and 23 hours after oral administration of ketotifen 1.38 mg and diphenhydramine 50 mg.

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Ketotifen 1.38 mg
Interventions/Control_2 Diphenhydramine 50 mg
Interventions/Control_3
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
Email 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
Email yanai@med.tohoku.ac.jp

Sponsor
Institute Department of Pharmacology, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Pharmacology, Tohoku University Graduate School of Medicine
NEDO microdose project
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 東北大学大学院医学系研究科機能薬理学分野
Tohoku University Graduate School of Medicine, Department of Pharmacology

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 05 Day

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
Results
Brain histamine H1 receptors were measured using PET and [11C]doxepin at 3 hours and 23 hours consecutively after diphenhydramine (50 mg) or ketotifen (1 mg) intake in healthy, young male subjects. The half-life of
diphenhydramine and ketotifen in the brain was estimated to be ~30 hours and 45 hours, respectively.
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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information Yanai K, et al. Histamine H1 Receptor Occupancy in Human Brain. In: Histamine Receptors:Preclinical and Clinical Aspects.Springer 2016: pp311-325. ISBN: 978-3-319-40306-9

Management information
Registered date
2013 Year 08 Month 05 Day
Last modified on
2017 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013278

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.