Official Title: “A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)”

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

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: levocetirizine dihydrochloride

Primary Measures

• pruritus severity, assessed by the investigator over 2 weeks of treatment
  • Time Frame: 2 weeks
    

Secondary Measures

• Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety
  • Time Frame: 2 weeks
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: UCB

Overall Clinical Trial Officials and Contacts

Isabelle Campine Study Director UCB  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00525382

Study ID Number: A00334

ClinicalTrials.gov Identifier: NCT00525382

Health Authority: China: Department of Health, Pharmaceuticals registration and Import/Export control section