UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000859 |
|---|---|
| Receipt number | 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 20:45:12 |
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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
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001032
