UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Naoki UCHIDA MD.,PhD
Organization	Showa University School of Medicine
Division name	Second department of Pharmacology
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	Naoki UCHIDA MD.,PhD
Organization	Showa University School of Medicine
Division name	Second department of Pharmacology
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2005 Year 10 Month 11 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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
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-bin/ctr_e/ctr_view.cgi?recptno=R000000346