UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005751 |
|---|---|
| Receipt number | R000006800 |
| Scientific Title | The effect of H1-antihistamine on equilibrium: a double-blind, placebo-controlled study in healthy volunteers |
| Date of disclosure of the study information | 2011/06/10 |
| Last modified on | 2011/06/10 10:05:12 |
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Basic information
Public title
The effect of H1-antihistamine on equilibrium: a double-blind, placebo-controlled study in healthy volunteers
Acronym
The effect of H1-antihistamine on pustural control
Scientific Title
The effect of H1-antihistamine on equilibrium: a double-blind, placebo-controlled study in healthy volunteers
Scientific Title:Acronym
The effect of H1-antihistamine on pustural control
Region
| Japan |
Condition
Condition
Allergic diseases
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Little is known about the effects of first-generation H1-antihistamines on postural stability. This study was conducted in order to evaluate the effects of d-chlorpheniramine on postural stability.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study was conducted in order to evaluate the effects of d-chlorpheniramine on postural stability using posturography with and without foam rubber. Postural sway was measured before and after medication.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Nine healthy volunteers were recruited and orally administered d-chlorpheniramine 2 mg.
Interventions/Control_2
Nine healthy volunteers were recruited and orally administered d-chlorpheniramine 4 mg.
Interventions/Control_3
Nine healthy volunteers were recruited and orally administered placebo.
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
| 21 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
We enrolled 27 healthy, young adult volunteers.
Key exclusion criteria
All subjects had unremarkable medical histories and no history of vertigo, hearing loss, or visual problems except for standard refractive errors.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Chihara |
Organization
Tokyo Postal Services Agency Hospital
Division name
Department of Otolaryngology
Zip code
Address
2-14-23 Fujimi, Chiyoda-ku, Tokyo, Japan
TEL
+81-3-5214-7111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Chihara |
Organization
The University of Tokyo
Division name
Department of Otolaryngology
Zip code
Address
TEL
Homepage URL
y-chihara@umin.ac.jp
Sponsor or person
Institute
Tokyo Postal Services Agency Hospital
Institute
Department
Personal name
Funding Source
Organization
Self Funding, Japanese Ministry of Education, Culture, Sports, Science and Technology, Trust Account of University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
東京逓信病院
Tokyo Postal Services Agency Hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 06 | Month | 10 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2010 | Year | 07 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 10 | Day |
Last modified on
| 2011 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006800
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