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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000859
Receipt No. R000001032
Scientific Title Randomized, double blind, crossover clinical pharmacological study to evaluate the relationships between dose-, concentration in blood-, and sedative effect after histamine H1 receptor antagonist d-chlorpheniramine intake using saccadic eye movement analysis in healthy male volunteers
Date of disclosure of the study information 2007/10/20
Last modified on 2010/02/17

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Basic information
Public title Randomized, double blind, crossover clinical pharmacological study to evaluate the relationships between dose-, concentration in blood-, and sedative effect after histamine H1 receptor antagonist d-chlorpheniramine intake using saccadic eye movement analysis in healthy male volunteers
Acronym Evaluation of the sedative effect of histamine H1 receptor antagonist by eye movement analyzing system
Scientific Title Randomized, double blind, crossover clinical pharmacological study to evaluate the relationships between dose-, concentration in blood-, and sedative effect after histamine H1 receptor antagonist d-chlorpheniramine intake using saccadic eye movement analysis in healthy male volunteers
Scientific Title:Acronym Evaluation of the sedative effect of histamine H1 receptor antagonist by eye movement analyzing system
Region
Japan

Condition
Condition Healthy male volunteers
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is evaluate relationships between dose-, concentration in blood, and sedative effect after histamine H1 receptor antagonist d-chlorpheniramine intake using saccadic eye movement analysis
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Saccadic eye movement peak velocity
Key secondary outcomes Visual analogue scale
Plasma concrntration of chlorpheniramine

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 d-Chlorpheniramine maleate 1 mg single oral dose
Interventions/Control_2 d-Chlorpheniramine maleate 2 mg single oral dose
Interventions/Control_3 d-Chlorpheniramine maleate 4 mg single oral dose
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

Not applicable
Gender Male
Key inclusion criteria 1. Healthy male volunteer
2. Subjects are competent to consent, keep the rules of the study and are able to report self condition
3.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 6

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
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
TEL
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 Grant-in Aid for Young Scientists (B)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Tsukuba Clinical Pharmacology Center Kan-nondai Clinic
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 10 Month 20 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 Completed
Date of protocol fixation
2007 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2007 Year 10 Month 01 Day
Last follow-up date
2007 Year 11 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
2007 Year 10 Month 19 Day
Last modified on
2010 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001032

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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