CUTE (Chronic Urticaria Treatment Evaluation)

Chronic Idiopathic Urticaria Clinical Trial

Official title:

A Comparative Study on Clinical Efficacy and Safety of Levocetirizine 5 mg Oral Capsules Once Daily in the Morning vs. Desloratadine 5 mg Oral Capsules Once Daily in the Morning in Patients Suffering From Chronic Idiopathic Urticaria (CIU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00264303
• Other study ID #: A00394
• Secondary ID: EudraCT 2005-000
• Status: Completed
• Phase: Phase 4
• First received: December 8, 2005
• Last updated: August 30, 2011
• Start date: December 2005
• Est. completion date: January 2007

Study information

• Verified date: June 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHPFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 886
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Idiopathic Urticaria
• Urticaria

Intervention

Drug:
• Levocetirizine
5mg oral capsules, once daily, 4 week duration
• Desloratadine
5mg oral capsules, once daily, 4 week duration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Malaysia,  Romania,  South Africa,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Pruritus Severity Score 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.	over the first week of treatment	No
Secondary	Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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.	over the first week of treatment	No
Secondary	Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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.	over the four weeks of treatment	No
Secondary	Mean Pruritus Severity Score 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.	over the four weeks of treatment	No
Secondary	Mean Score for Pruritus Duration 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.	over the first week of treatment	No
Secondary	Mean Score for Pruritus Duration 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.	over the four weeks of treatment	No

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