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Study of optimal treatment duration with antihistamine in idiopathic urticaria patients

Study of optimal treatment duration with antihistamine in idiopathic urticaria patients - Urticaria Dose optimized trial (SOLIDARITIE)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001163
Enrollment
120
Registered
2008-05-23
Start date
2007-12-01
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

Four week-treatment with fexofenadine (120 mg/day) group Untreatment observation group

Sponsors

West Japan Urticaria Therapy Study Group
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Cumulative recurrence rate at 3 months after relief of urticaria symptoms (signs)

Secondary

MeasureTime frame
1. Cumulative recurrence rate at 4 and 8 weeks after the relief of urticaria symptoms(signs) 2. Safety

Countries

Japan

Contacts

Public ContactMotoaki Inoue

Clinical Research Support Center Kyusyu Secretariat

inoue@cres-kyushu.or.jp092-631-2920

Outcome results

None listed

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