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.

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. - Clinical pharmacological study to evaluate a sedative effect of histamine H1 receptor antagonist diphenhyroamine (Drewell®) in elderly male.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000274

Enrollment

Registered

2006-01-31

Start date

2005-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Japanese healthy elderly male volunteers

Interventions

Diphenhydramine 50mg single oral dose group Matched placebo group

Eligibility

Sex/Gender

Male

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Saccadic eye movement peak velocity	—

Secondary

Measure	Time frame
Other saccadic eve movement parameters (latency, inaccuracy) Visual analogue scale alertness score Plasma concentration of diphenhydramine	—

Countries

Japan

Contacts

Public ContactNaoki UCHIDA MD.,PhD

Showa University School of Medicine Second department of Pharmacology

nuchida@med.showa-u.ac.jp03-3784-8128

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Placebo control, double blind, crossover clinical pharmacological study to evaluate a sedative effect after histamine H1 receptor antagonist diphenhydroamine (Drewell&reg;) administration by using saccadic eye movement analyzing system in healthy Japanese elderly male volunteers.