Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria
Phase 3
Completed
- Conditions
- Urticaria
- Registration Number
- NCT00525382
- Lead Sponsor
- UCB Pharma
- Brief Summary
Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method pruritus severity, assessed by the investigator over 2 weeks of treatment 2 weeks
- Secondary Outcome Measures
Name Time Method Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety 2 weeks