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Completed

NCT Number: NCT00264303

CUTE (Chronic Urticaria Treatment Evaluation)

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

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Key information

Conditions

Chronic Idiopathic Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levocetirizine

Drug

5mg oral capsules, once daily, 4 week duration

desloratadine

Drug

5mg oral capsules, once daily, 4 week duration

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Dec 12, 2005
Registry last updated
Aug 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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