UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000003 |
|---|---|
| Receipt number | R000000008 |
| Scientific Title | Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydramine administration by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers |
| Date of disclosure of the study information | 2005/06/02 |
| Last modified on | 2016/04/09 12:00:20 |
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Basic information
Public title
Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydramine administration by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers
Acronym
Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyramine
Scientific Title
Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydramine administration by using saccadic eye movement analyzing system and visual analogue scale (VAS) in healthy Japanese male volunteers
Scientific Title:Acronym
Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyramine
Region
| Japan |
Condition
Condition
Japanese healthy male volunteers
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate a sedative effect of oral single dose of diphenhydramine 50mg with both saccadic eye movement analysis as a subjective evaluation and Visual Analogue Scale (VAS) as an objective evaluation. And PK/PD analysis is also performed.
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
Other saccadic eve movement parameters (latency, inaccuracy)
Visual analogue scale alertness score
Plasma concentration of diphenhydramine
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diphenhydramine 50mg 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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1.Healthy Japanese male volunteer
2.Age from 20<= <40
3.Subjects who can report self condition
4.Without clinically significant abnormalities in a series of screening examination
5.Written informed consent
Key exclusion criteria
1.Any clinically significant history of drug abuse, alcoholic abuse, heart, liver, kidney, lung, and blood disease etc. thought to be not eligible to participate in the study
2.Subjects known to treated with medicine which has a sedative effect or an antihistaminic agents
3.Subjects who can not abstaine from smoking during study period
4.Any drug allergy history
5.Subjects who is using excessive alcohol regularly (cannot keep abstinence for study period)
6.Perticipation in any clinical trial within 3 months
7.Donation of more than 200mL blood within 3 months
8.Any use of drugs in the 2 weeks prior to study drug administration
9.Subjects who, in the opinion of the investigator, are not likely to participate in the study for any reason
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki UCHIDA MD.,PhD |
Organization
Showa University School of Medicine
Division name
Second department of Pharmacology
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8128
nuchida@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki UCHIDA MD., PhD |
Organization
Showa University School of Medicine
Division name
Second department of Pharmacology
Zip code
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo 142-8555
TEL
03-3784-8128
Homepage URL
nuchida@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University School of Medicine Second department of Pharmacology
Institute
Department
Personal name
Funding Source
Organization
The Special Subsidies in Subsidies for ordinary expenses of private schools from the Ministry of Education, Culture, Sports, Science and Technology in 2005.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Yakusen-kai Kannondai Clinic
Name of secondary funder(s)
Not applicable
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
| 2005 | Year | 06 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The pharmacokinetics parameters of diphenhydramine in this study were similar to those reported previously.
Values of Saccadic Peak Velocity (SPV), as a subjective parameter of sedative effect, and also values of sedative score of Visual Analogue Scale (VAS) in the Drewell group from 30 minutes to 180 minutes after drug administration declined significantly (p<0.05 paired t-test followed by repeated measures ANOVA).
There was no significant difference in Latency and in Inaccuracy.
SPV decreased with increasing plasma diphenhydramine concentration, and SPV recovered to baseline value with decreasing plasma diphenhydramine concentration. But there was a subject whose SPV change was not related to blood concentration levels.
Jpn. J Clin. Pharmacol. Ther., 36(Suppl): S243, 2005
Jpn. J Clin. Pharmacol. Ther., 37(1): 55-64, 2006
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
| 2004 | Year | 12 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2005 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2005 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2005 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2005 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 02 | Day |
Last modified on
| 2016 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000008
