CUTE (Chronic Urticaria Treatment Evaluation)

August 30, 2011 updated by: UCB Pharma

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

886

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Liege, Belgium
      • Merksem, Belgium
      • Sint-Niklaas, Belgium
      • Woluwe-St-Lamb, Belgium
  • France
      • Bernay, France
      • Besancon, France
      • Hyeres, France
      • Les Milles, France
      • Marseille, France
      • Montpellier, France
      • Nancy, France
      • Nantes, France
      • Nice, France
      • Nimes, France
      • Paris, France
      • Poitiers, France
      • Quimper, France
      • Saint-Mande, France
      • Troyes, France
      • Valence, France
      • Villejuif, France
  • Germany
      • Augsburg, Germany
      • Berlin, Germany
      • Dresden, Germany
      • Dusseldorf, Germany
      • Erlangen, Germany
      • Gottingen, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Koln, Germany
      • Leipzig, Germany
      • Mahlow, Germany
      • Mainz, Germany
      • Munchen, Germany
      • Viersen, Germany
  • Italy
      • Caserta, Italy
      • Catania, Italy
      • Cesena, Italy
      • Genova, Italy
      • Modena, Italy
      • Palermo, Italy
      • Pavia, Italy
      • Roma, Italy
      • Siena, Italy
      • Udine, Italy
      • Verona, Italy
  • Malaysia
      • Johor Bharu, Malaysia
      • Kelantan, Malaysia
      • Kuala Lumpur, Malaysia
      • Negeri Sembilan, Malaysia
      • Perak, Malaysia
      • Pulau Pinang, Malaysia
      • Sarawak, Malaysia
  • Romania
      • Brasov, Romania
      • Bucharest, Romania
      • Dolj, Romania
      • Sibiu, Romania
  • South Africa
      • Cape Town, South Africa
      • Durban, South Africa
      • Lenasia, South Africa
  • Spain
      • Albacete, Spain
      • Barcelona, Spain
      • Coruna, Spain
      • Granada, Spain
      • Madrid, Spain
      • Malaga, Spain
      • Murcia (El Palmar), Spain
      • Oviedo, Spain
      • Santiago de Compostela, Spain
      • Sevila, Spain
      • Valencia, Spain
  • United Kingdom
      • Amersham, United Kingdom
      • Cardiff, United Kingdom
      • Irvine, United Kingdom
      • Leicester, United Kingdom
      • London, United Kingdom
      • Nuneaton, United Kingdom
      • Salford, United Kingdom

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levocetirizine
Levocetirizine, once daily, 4 week duration
Drug: Levocetirizine
5mg oral capsules, once daily, 4 week duration
Active Comparator: Desloratadine
Desloratadine, once daily, 4 week duration
Drug: Desloratadine
5mg oral capsules, once daily, 4 week duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Pruritus Severity Score Over the First Week of Treatment
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
Time Frame: 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
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
Time Frame: 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
Mean Pruritus Severity Score Over the Four Weeks of Treatment
Time Frame: 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
Mean Score for Pruritus Duration Over the First Week of Treatment
Time Frame: 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
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

December 8, 2005

First Submitted That Met QC Criteria

December 8, 2005

First Posted (Estimate)

December 12, 2005

Study Record Updates

Last Update Posted (Estimate)

August 31, 2011

Last Update Submitted That Met QC Criteria

August 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A00394
  • EudraCT 2005-000358-65
  • CUTE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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