UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010265 |
|---|---|
| Receipt number | R000011623 |
| Scientific Title | Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria |
| Date of disclosure of the study information | 2013/03/21 |
| Last modified on | 2019/01/24 19:09:19 |
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Basic information
Public title
Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria
Acronym
Preliminary trial for the increase of antihistamines on refractory urticaria
Scientific Title
Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria
Scientific Title:Acronym
Preliminary trial for the increase of antihistamines on refractory urticaria
Region
| Japan |
Condition
Condition
idiopathic urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain a preliminary data for a study to evaluate the adequate way of administration of antihistamines in dose or number for refractory spontaneous urticarial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of complete response
Key secondary outcomes
Days to be symptom free
Change of symptom scores during treatments
sleepiness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Levocetirizine 10mg/day oral intake
Interventions/Control_2
Levocetirizine 5mg/day and chlorpheniramine maleate 4mg/day oral intake
Interventions/Control_3
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult subject with spontaneous urticaria.
Without reduction of daily urticaria scores being 4 or more in 3 days or more, after 7 days treatment with 5mg/day levocetirizine. Or with reductions of daily urticaria score 1 or more in 3 days or more, out of 7 days by taking lecocetirizine 5mg/day, and with daily urticarial score 4 or more in the last three days of the following 1 week treatment.
Granted with written informed consent.
Able to score daily urticaria activities according to the formatted urticaria diary.
Agreed to re-visit the clinic for evaluation.
Key exclusion criteria
A history of drug allergy.
Pregnant or lactating.
Glaucoma, hyper intraocular pressure or inferior urinary tract obstruction.
Hyperthyroidism or any cardiovascular disease.
Stegnotic gastrointestinal ulceration or pylorus stegnosis.
Taking central nervous depressant, alcohol, MAO inhibitor or anti-choline agent.
Disease that discourages from taking anti- cholinergic drugs or antihistamines.
High renal or liver damage.
Decreased cognitive ability or comprehension.
Histories of taking anti-leukotriene or H2-blocker within two weeks before agreement.
Histories of taking steroids by strongest class topical application or injection within four weeks before agreement.
Occupation driving or operating machines.
Any patients evaluated as inadequate by physicians.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michihiro Hide |
Organization
Hiroshima university hospital
Division name
Department of dermatology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551
TEL
082-257-5237
ed1h-w1de-road@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Hanaoka |
Organization
Hiroshima university hospital
Division name
Department of Dermatology
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551
TEL
082-257-5237
Homepage URL
keikouh@msi.biglobe.ne.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
広島大学病院(広島県)
広島市立安佐市民病院(広島県)
県立広島病院(広島県)
マツダ病院(広島県)
JA広島総合病院(広島県)
府中水野皮ふ科クリニック(広島県)
水野皮ふ科(広島県)
古谷皮ふ科クリニック(広島県)
かめよし皮ふ科・アレルギー科(広島県)
村尾皮ふ科クリニック(広島県)
酒井耳鼻咽喉科皮ふ科医院(広島県)
山本皮膚科医院(広島県)
森皮ふ科アレルギー科(広島県)
瀬分皮膚科アレルギー科(広島県)
しのだ皮ふ科(広島県)
もちづき皮ふ科・アレルギー科(広島県)
たなか皮ふ科アレルギー科(広島県)
岡原皮ふ科クリニック(広島県)
にいみ皮ふ科アレルギー科(広島県)
わたえだ皮膚科クリニック(広島県)
佐藤皮ふ科クリニック(広島県)
岩崎皮ふ科・形成外科(広島県)
こうろ皮ふ科(広島県)
弓立皮膚科クリニック
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 21 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 18 | Day |
Last modified on
| 2019 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011623
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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