CUTE (Chronic Urticaria Treatment Evaluation)

NCT ID: NCT00264303

Last Updated: 2011-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

886 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-01-31

Brief Summary

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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

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Conditions

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Chronic Idiopathic Urticaria

Keywords

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Chronic Idiopathic Urticaria CUTE Levocetirizine Xyzal®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Levocetirizine

Levocetirizine, once daily, 4 week duration

Group Type EXPERIMENTAL

Levocetirizine

Intervention Type DRUG

5mg oral capsules, once daily, 4 week duration

Desloratadine

Desloratadine, once daily, 4 week duration

Group Type ACTIVE_COMPARATOR

Desloratadine

Intervention Type DRUG

5mg oral capsules, once daily, 4 week duration

Interventions

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Levocetirizine

5mg oral capsules, once daily, 4 week duration

Intervention Type DRUG

Desloratadine

5mg oral capsules, once daily, 4 week duration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

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Bruges, , Belgium

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Brussels, , Belgium

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Liège, , Belgium

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Merksem, , Belgium

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Sint-Niklaas, , Belgium

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Woluwe-St-Lamb, , Belgium

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Bernay, , France

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Besançon, , France

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Hyères, , France

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Les Milles, , France

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Marseille, , France

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Montpellier, , France

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Nancy, , France

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Nantes, , France

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Nice, , France

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Nîmes, , France

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Paris, , France

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Poitiers, , France

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Quimper, , France

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Saint-Mandé, , France

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Troyes, , France

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Valence, , France

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Villejuif, , France

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Augsburg, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Düsseldorf, , Germany

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Erlangen, , Germany

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Göttingen, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Leipzig, , Germany

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Mahlow, , Germany

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Mainz, , Germany

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München, , Germany

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Viersen, , Germany

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Caserta, , Italy

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Catania, , Italy

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Cesena, , Italy

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Genova, , Italy

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Modena, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Roma, , Italy

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Siena, , Italy

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Udine, , Italy

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Verona, , Italy

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Johor Bharu, , Malaysia

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Kelantan, , Malaysia

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Kuala Lumpur, , Malaysia

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Negeri Sembilan, , Malaysia

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Perak, , Malaysia

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Pulau Pinang, , Malaysia

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Sarawak, , Malaysia

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Brasov, , Romania

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Bucharest, , Romania

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Dolj, , Romania

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Sibiu, , Romania

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Cape Town, , South Africa

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Durban, , South Africa

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Lenasia, , South Africa

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A Coruña, , Spain

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Albacete, , Spain

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Barcelona, , Spain

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Granada, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Murcia (El Palmar), , Spain

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Oviedo, , Spain

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Santiago de Compostela, , Spain

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Seville, , Spain

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Valencia, , Spain

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Amersham, , United Kingdom

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Cardiff, , United Kingdom

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Irvine, , United Kingdom

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Leicester, , United Kingdom

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London, , United Kingdom

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Nuneaton, , United Kingdom

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Salford, , United Kingdom

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Countries

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Belgium France Germany Italy Malaysia Romania South Africa Spain United Kingdom

Related Links

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Other Identifiers

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EudraCT 2005-000358-65

Identifier Type: -

Identifier Source: secondary_id

CUTE

Identifier Type: -

Identifier Source: secondary_id

A00394

Identifier Type: -

Identifier Source: org_study_id