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CUTE (Chronic Urticaria Treatment Evaluation)

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ClinicalTrials.gov Identifier: NCT00264303
Recruitment Status : Completed
First Posted : December 12, 2005
Results First Posted : July 9, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Urticaria Drug: Levocetirizine Drug: Desloratadine Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 886 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : December 2005
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives Itching
U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00264303


  Show 80 Study Locations
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)

Additional Information:
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00264303     History of Changes
Other Study ID Numbers: A00394
EudraCT 2005-000358-65
CUTE
First Posted: December 12, 2005    Key Record Dates
Results First Posted: July 9, 2009
Last Update Posted: August 31, 2011
Last Verified: June 2011

Keywords provided by UCB Pharma:
Chronic Idiopathic Urticaria
CUTE Levocetirizine Xyzal®

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Levocetirizine
Cetirizine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Anti-Allergic Agents