UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000567 |
|---|---|
| Receipt number | R000000686 |
| Scientific Title | Randomized, placebo-controlled, single blind, crossover clinical study to evaluate the relationship between subjective sedation after a single dose of ebastine and gene polymorphisms in pharmacodynamics and pharmacokinetics of ebastine. The healthy Japanese volunteers had experience with subjective sedation after taking the second generation histamine H1 receptor antagonists. |
| Date of disclosure of the study information | 2007/03/01 |
| Last modified on | 2010/11/06 14:12:04 |
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Basic information
Public title
Randomized, placebo-controlled, single blind, crossover clinical study to evaluate the relationship between subjective sedation after a single dose of ebastine and gene polymorphisms in pharmacodynamics and pharmacokinetics of ebastine. The healthy Japanese volunteers had experience with subjective sedation after taking the second generation histamine H1 receptor antagonists.
Acronym
Clinical study on sedative effect of histamine H1 receptor antagonist ebastine.
-Study on gene polymorphisms associated with individual difference in subjective symptoms.-
Scientific Title
Randomized, placebo-controlled, single blind, crossover clinical study to evaluate the relationship between subjective sedation after a single dose of ebastine and gene polymorphisms in pharmacodynamics and pharmacokinetics of ebastine. The healthy Japanese volunteers had experience with subjective sedation after taking the second generation histamine H1 receptor antagonists.
Scientific Title:Acronym
Clinical study on sedative effect of histamine H1 receptor antagonist ebastine.
-Study on gene polymorphisms associated with individual difference in subjective symptoms.-
Region
| Japan |
Condition
Condition
Japanese healthy volunteers who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist.
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The purpose of this study is to evaluate the relationship between subjective sedation after a single dose of ebastine 10 mg and gene polymorphisms of MDR1, BCRP, CYP3A4, CYP2J2, CYP4F12 and HRH1. These are known to be involved in pharmacodynamics and pharmacokinetics of ebastine in human. The volunteers had experience with subjective sedation after taking second generation histamine H1 receptor antagonists.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency distribution for MDR1, BCRP, CYP3A4, CYP2J2, CYP4F12 and HRH1 genotypes are evaluated in each group of subjective sedation scored by alertness score of VAS.
Key secondary outcomes
Alertness score of VAS, the number of words typed and the number of mistyped characters are evaluated in each group of genotype.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ebastine 10mg single oral dose group
Interventions/Control_2
Matched placebo group
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy volunteers age from 20 to less than 45 years old.
2. Subjects who had experience with subjective sedation after taking the second generation of histamine H1 receptor antagonist by questionnaire survey.
3. Subjects are competent to consent, keep the rules of the study and are able to report self condition.
4. Subjects who are judged eligible by the investigator in several series of medical check.
Key exclusion criteria
1. Inappropriate clinical history for medication study (i.e. drug abuse, alcoholism, diseases of heart, liver, kidney, lung, and blood etc.) or who are ambulatory patients suffering theses diseases.
2. Subjects who are ingested medicine with sedatives or antihistaminic agents during this study.
3. Smoker
4. Any history for drug allergy.
5. Severe alcoholism.
6. Subjects who are inadequate for enrollment judged by the investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori YAMAMOTO PhD. |
Organization
Showa University School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko KOHYAMA PhD. |
Organization
Showa University School of Pharmaceutical Sciences
Division name
Department of Clinical Pharmacy
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8221
Homepage URL
noriko-kyb@pharm.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Pharmaceutical Sciences
Department of Clinical Pharmacy
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Showa University School of Medicine Second Department of Pharmacology
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Terminated
Date of protocol fixation
| 2006 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 12 | Month | 28 | Day |
Last modified on
| 2010 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000686
