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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000000567
Receipt No. 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

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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
Email

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
Email noriko-kyb@pharm.showa-u.ac.jp

Sponsor
Institute Showa University School of Pharmaceutical Sciences
Department of Clinical Pharmacy
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000686

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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