UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria
Title of the study (Brief title)	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	Michihiro Hide
Organization	Hiroshima university hospital
Division name	Department of dermatology
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	Keiko Hanaoka
Organization	Hiroshima university hospital
Division name	Department of Dermatology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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