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

Study Timeline

• Study Start: 2003-08
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-04
• Study First Posted: 2007-09-05
• Status Verified: 2009-09
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

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