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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010265
Receipt No. 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

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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
Email 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
Email keikouh@msi.biglobe.ne.jp

Sponsor
Institute Hiroshima university
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011623

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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