UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004527 |
|---|---|
| Receipt number | 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 11:24:57 |
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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
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
noriko-kyb@pharm.showa-u.ac.jp
Sponsor or person
Institute
Department of Clinical Pharmacy, School of Pharmacy, Showa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005394
