Urticaria
Conditions
Keywords
Levocetirizine dihydrochloride, Xyzal tablets
Brief summary
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.
Interventions
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female, 18 to 60 years old (inclusive * having chronic idiopathic urticaria * at least 6-weeks history of CIU, had at least 3 days of wheals presence/week * moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization
Exclusion criteria
* Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn * atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids * urticaria caused by physical factors or other known factors * cholinergic urticaria * had urticaria due to other systemic disorders * were on antihistamine drug currently
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pruritus severity, assessed by the investigator over 2 weeks of treatment | 2 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety | 2 weeks |
Outcome results
None listed