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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004527
Receipt No. R000005394
Scientific Title Randomized, double blind, crossover clinical study to evaluate the sedative effect after the treatment of 1 mg dose of ketotifen, or 10 or 20 mg dose of cetirizine using saccadic eye movement analysis in healthy male volunteers
Date of disclosure of the study information 2010/11/09
Last modified on 2010/12/27

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Basic information
Public title Randomized, double blind, crossover clinical study to evaluate the sedative effect after the treatment of 1 mg dose of ketotifen, or 10 or 20 mg dose of cetirizine using saccadic eye movement analysis in healthy male volunteers
Acronym Evaluation of the sedative effect by ketotifen or cetirizine treatment using saccadic eye movement analysis
Scientific Title Randomized, double blind, crossover clinical study to evaluate the sedative effect after the treatment of 1 mg dose of ketotifen, or 10 or 20 mg dose of cetirizine using saccadic eye movement analysis in healthy male volunteers
Scientific Title:Acronym Evaluation of the sedative effect by ketotifen or cetirizine treatment using saccadic eye movement analysis
Region
Japan

Condition
Condition allergic rhinitis, pollen allergy
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the sedative effect of ketotifen (1mg) and cetirizine (10 or 20mg) by measuring saccadic peak velocity (SPV) as primary outcome using saccadic eye movement analysis. Based on the SPV's results, we subsequently analyzed the correlationship between the SPV and the published histamine H1 receptor occupancy in the brain.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Saccadic peak velocity
Key secondary outcomes Latency
Inaccuracy
Visual Analogue Scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Historical
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 Single dose of Ketotifen (1 mg) by oral route
Interventions/Control_2 Single dose of Cetirizine (10 mg) by oral route
Interventions/Control_3 Single dose of Cetirizine (20 mg) by oral route
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
35 years-old >=
Gender Male
Key inclusion criteria Healthy volunteers enrolled this study must be agreement with the following criteria:
1.Age between 20 and 35
2.Male
3.Subjects are competent to consent, keep the rule of this study and are able to report self condition
4.Subjects who are judged eligible by the investigator in several series of medical check
Key exclusion criteria 1.Subjects who have inappropriate medical history (ex., drug abuse, alcoholism, any kind of heart, liver, kidney, lung, eye and blood diseases etc.) or who are ingested medicine during this study.
2.Smoker.
3.Any drug allergy.
4.Subjects who are using excessive alcohol regularly (cannot keep abstinence for study period)
5.Nocturnal habits during night.
6.Participation in any clinical trial within the last 3 months.
7.Subjects who are inadequate for enrollment judged by the investigators.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori YAMAMOTO
Organization School of Pharmacy, Showa University
Division name Department of Clinical Pharmacy
Zip code
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555
TEL 03-3784-8221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Noriko KOHYAMA
Organization School of Pharmacy, Showa University
Division name Department of Clinical Pharmacy
Zip code
Address
TEL
Homepage URL
Email noriko-kyb@pharm.showa-u.ac.jp

Sponsor
Institute Department of Clinical Pharmacy, School of Pharmacy, Showa University
Institute
Department

Funding Source
Organization Department of Clinical Pharmacy, School of Pharmacy, Showa University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Second Department of Pharmacology, School of Medicine, Showa University
Tokyo Heart Center, Dept of Clinical Pharmacology Laboratory
Name of secondary funder(s) Showa University Research Grant for Young Researchers

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 医療法人社団冠心会大崎病院東京ハートセンター臨床薬理研究所(東京都)

Other administrative information
Date of disclosure of the study information
2010 Year 11 Month 09 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
2010 Year 10 Month 27 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2010 Year 11 Month 01 Day
Date of closure to data entry
2010 Year 12 Month 01 Day
Date trial data considered complete
2010 Year 12 Month 01 Day
Date analysis concluded
2010 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 11 Month 09 Day
Last modified on
2010 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005394

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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