UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007182 |
|---|---|
| Receipt number | R000008461 |
| Scientific Title | Comparative trials of Olopatadine and Fexofenadine on histamine iontophoresis induced urticaria |
| Date of disclosure of the study information | 2012/02/17 |
| Last modified on | 2012/06/20 21:56:35 |
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Basic information
Public title
Comparative trials of Olopatadine and Fexofenadine on histamine iontophoresis induced urticaria
Acronym
Comparative trials of Olopatadine and Fexofenadine on histamine iontophoresis induced urticaria (OF trial)
Scientific Title
Comparative trials of Olopatadine and Fexofenadine on histamine iontophoresis induced urticaria
Scientific Title:Acronym
Comparative trials of Olopatadine and Fexofenadine on histamine iontophoresis induced urticaria (OF trial)
Region
| Japan |
Condition
Condition
Urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Compare the effect of regular dose of Olopatadine and regular dose of Fexofenadine on histamine iontophoresis induced urticaria
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
Wheal area
Key secondary outcomes
Flare area, VAS for itching
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
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Placebo
Interventions/Control_2
Olopatadine 5mg
Interventions/Control_3
Fexofenadine 60mg
Interventions/Control_4
Fexofenadine 120mg
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
| 45 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Participants should consent to this trial with written agreement form.
2. Male and female
3. From 20 years old to 44 years old
4. From 50 kg to 85 kg in body weight
5. From 18.5 to 25.0 in body mass index
6. Nonsmoker
Key exclusion criteria
1. Participate in other trial within 120 days.
2. Taking some medicine
3. History of drug allergy
4. History of sever skin disease
5. History of liver disease
6. History of heart disease
7. History of respiratory disease
8. History of digestive disease
9. History of kidney or cerebrovascular disease
10. History of malignancy
11. Low responder to histamine iontophoresis
12. Heavy drinker
13. Participant who judged as inadequate for this trial
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujio OTSUKA |
Organization
University of Tsukuba
Division name
Department of Dermatology, Faculty of Medicine
Zip code
Address
1-1-1, Ten-nohdai, Tsukuba, Ibaraki, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun-ichi FURUTA |
Organization
University of Tsukuba
Division name
Department of Dermatology, Faculty of Medicine
Zip code
Address
1-1-1, Ten-nohdai, Tsukuba, Ibaraki, Japan
TEL
Homepage URL
Sponsor or person
Institute
Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
株式会社SOUKEN 臨床試験室(東京都)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 17 | 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
| 2012 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 31 | Day |
Last modified on
| 2012 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008461
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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