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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


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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