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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000274
Receipt No. R000000346
Scientific Title Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydroamine (Drewell®) administration by using saccadic eye movement analyzing system in healthy Japanese elderly male volunteers.
Date of disclosure of the study information 2006/01/31
Last modified on 2016/04/09

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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 diphenhydroamine (Drewell®) administration by using saccadic eye movement analyzing system in healthy Japanese elderly male volunteers.
Acronym Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyroamine (Drewell®) in elderly male.
Scientific Title Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydroamine (Drewell®) administration by using saccadic eye movement analyzing system in healthy Japanese elderly male volunteers.
Scientific Title:Acronym Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyroamine (Drewell®) in elderly male.
Region
Japan

Condition
Condition Japanese healthy elderly male volunteers
Classification by specialty
Geriatrics 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 (Drewell®)in Japanese healthy elderly male 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
65 years-old <=
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria 1.Healthy Japanese male volunteer
2.Age from 65<=
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.Past history and/or present illness of glaucoma
4. Past history and/or present illness of prostatic hypertrophy or dysuria
5.Subjects who can not abstaine from smoking during study period
6.Any drug allergy history
7.Subjects who is using excessive alcohol regularly (cannot keep abstinence for study period)
8.Perticipation in any clinical trial within 3 months
9.Donation of more than 200mL blood within 3 months
10.Any use of drugs in the 1 weeks prior to study drug administration
11. Person who cannot do appropriate measurement according to the instruction at training session
12.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
Email 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
Email nuchida@med.showa-u.ac.jp

Sponsor
Institute Showa University School of Medicine Second department of Pharmacology
Institute
Department

Funding Source
Organization SS pharmacy cooperation
Organization
Division
Category of Funding Organization Profit organization
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
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
2006 Year 01 Month 31 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.
The values of Saccadic Peak Velocity (SPV) and also Inaccuracy (IAC), as a subjective parameter of sedative effect in the Drewell group from 90 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 Visual Analogue Scale (VAS), as a subjective parameter for sedation.

Jpn. J Clin. Pharmacol. Ther.,37(5), p283-290, 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
2005 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2005 Year 11 Month 01 Day
Last follow-up date
2005 Year 12 Month 01 Day
Date of closure to data entry
2006 Year 01 Month 01 Day
Date trial data considered complete
2006 Year 02 Month 01 Day
Date analysis concluded
2006 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 11 Month 02 Day
Last modified on
2016 Year 04 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000346

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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