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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001163
Receipt No. R000001095
Scientific Title Study of optimal treatment duration with antihistamine in idiopathic urticaria patients
Date of disclosure of the study information 2008/05/23
Last modified on 2020/06/03

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Basic information
Public title Study of optimal treatment duration with antihistamine in idiopathic urticaria patients
Acronym Urticaria Dose optimized trial (SOLIDARITIE)
Scientific Title Study of optimal treatment duration with antihistamine in idiopathic urticaria patients
Scientific Title:Acronym Urticaria Dose optimized trial (SOLIDARITIE)
Region
Japan

Condition
Condition Idiopathic urticaria
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the optimal duration of treatment with antihistamine after relief of symptoms/signs in patients with idiopathic urticaria, we compare immediately stopping treatment with 4 weeks prolonged treatment after the relief of symptoms/signs in patients with idiopathic urticaria by antihistamine.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Cumulative recurrence rate at 3 months after relief of urticaria symptoms (signs)
Key secondary outcomes 1. Cumulative recurrence rate at 4 and 8 weeks after the relief of urticaria symptoms(signs)
2. Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Four week-treatment with fexofenadine (120 mg/day) group
Interventions/Control_2 Untreatment observation group
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 Patients with idiopathic urticaria
1. Symptoms/signs free of urticaria for at least 48 hrs at the randomization
2. Symptom/signs are resolved in the period of 2-6 weeks from the onset of uritcaria
3. Not less than 20 years old (no upper limit)
4. Written informed consent
Key exclusion criteria 1. Pregnant or lactating women or women of child bearing potential not using contraception
2. Patients with a history of hypersensitivity to fexofenadine hydrochloride
3. Patients who use medications that interfere with the efficacy evaluation (e.g., other antihistamines, drugs with anti-allergy action, systemic steroids etc.)
4. Others whom the physician judges are not suitable as subjects
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Michichiro
Middle name
Last name hide
Organization Hiroshima University
Division name Department of Dermatology, Graduate School of Biomedical and Health Sciences
Zip code 734-8553
Address 1-2-3 Kasumi Minami-ku Hiroshima 734-8551
TEL 0822575235
Email ed1h-w1de-road@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Motoaki
Middle name
Last name Inoue
Organization Clinical Research Support Center Kyusyu
Division name Secretariat
Zip code 734-8551
Address Kasumi, Minami-ku
TEL 092-631-2920
Homepage URL http://www.cres-kyusyu.or.jp
Email inoue@cres-kyushu.or.jp

Sponsor
Institute West Japan Urticaria Therapy Study Group
Institute
Department

Funding Source
Organization Clinical Research Support Center Kyusyu
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hiroshima University Integrated Clinical Research Support Center
Address 1-2-3
Tel 0822571732
Email iryo-seisaku@office.hiroshima-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 23 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 No longer recruiting
Date of protocol fixation
2007 Year 10 Month 22 Day
Date of IRB
Anticipated trial start date
2007 Year 12 Month 01 Day
Last follow-up date
2010 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 05 Month 23 Day
Last modified on
2020 Year 06 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001095

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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