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Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria

Preliminary trial of the increase of antihistamines in dose and a combination of different antihistamine on refractory spontaneous urticaria - Preliminary trial for the increase of antihistamines on refractory urticaria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000010265
Enrollment
32
Registered
2013-03-21
Start date
2013-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic urticaria

Interventions

Levocetirizine 10mg/day oral intake Levocetirizine 5mg/day and chlorpheniramine maleate 4mg/day oral intake

Sponsors

Hiroshima university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Rate of complete response

Secondary

MeasureTime frame
Days to be symptom free Change of symptom scores during treatments sleepiness

Countries

Japan

Contacts

Public ContactKeiko Hanaoka

Hiroshima university hospital Department of Dermatology

keikouh@msi.biglobe.ne.jp082-257-5237

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026