CUTE (Chronic Urticaria Treatment Evaluation)

Phase 4

Completed

• Conditions: Chronic Idiopathic Urticaria
• Interventions: Drug: Levocetirizine; Drug: Desloratadine

• Registration Number: NCT00264303
• Lead Sponsor: UCB Pharma

Brief Summary

A study to compare the clinical efficacy and safety of Levocetirizine vs. Desloratadine in patients suffering from Chronic Idiopathic Urticaria (CIU) measured by the mean pruritus severity score over the first week of treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2005-12-08
• Study First Submitted QC: 2005-12-08
• Study First Posted: 2005-12-12
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Results First Submitted: 2009-05-18
• Results First Submitted QC: 2009-05-18
• Results First Posted: 2009-07-09
• Status Verified: 2011-06
• Last Update Submitted: 2011-08-30
• Last Update Posted: 2011-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 886

Inclusion Criteria

• At visit 1: Clinical history of Chronic Idiopathic Urticaria for a period of at least 6 weeks during the last 3 months without an identifiable cause

• At visit 2 (after a baseline period of at least 3 days): patient with adequate signs of CIU, both in terms of symptoms and severity.

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Exclusion Criteria

• Any condition that would interfere with the evaluation of the therapeutic response.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levocetirizine	Levocetirizine	Levocetirizine, once daily, 4 week duration
Desloratadine	Desloratadine	Desloratadine, once daily, 4 week duration

Primary Outcome Measures

Name	Time	Method
Mean Pruritus Severity Score Over the First Week of Treatment	over the first week of treatment	Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate). Mean pruritus severity score is averaged over the first week of treatment.

Secondary Outcome Measures

Name	Time	Method
Mean Score for Pruritus Duration Over the First Week of Treatment	over the first week of treatment	The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the first week of treatment.
Mean Score for Pruritus Duration Over the Four Weeks of Treatment	over the four weeks of treatment	The pruritus duration score is evaluated on an ordinal 4-point scale (0=no pruritus, 1=less than 1 hour, 2=1 to 6 hours, 3=more than 6 hours). Mean score for pruritus duration is averaged over the four weeks of treatment.
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment	over the first week of treatment	CIU composite score is defined as the sum of 2 scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 1st week of treatment.
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment	over the four weeks of treatment	CIU composite score is defined as the sum of two scores defined on an ordinal 4-point scale (pruritus severity score: 0=none, 1=mild, 2=moderate, 3=severe/intense; score for the number of wheals/24 h: 0=none, 1=mild or \<=20 wheals, 2=moderate or 21-50 wheals/24 h, 3=severe/intense or \>50 wheals/24 h). Mean is averaged over the 4 weeks of treatment.
Mean Pruritus Severity Score Over the Four Weeks of Treatment	over the four weeks of treatment	Pruritus severity is evaluated on an ordinal 4-point scale from 0 to 3 (0=none, 1=mild, 2=moderate, 3=severe/intense). Mean pruritus severity score is averaged over the four weeks of treatment.