Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

UCB

Status and phase: Completed; Phase 3

Conditions: Urticaria

Treatments: Drug: levocetirizine dihydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00525382

A00334

Details and patient eligibility

About

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

Enrollment: 134 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind