CUTE (Chronic Urticaria Treatment Evaluation)
This study has been completed.
Sponsor:
UCB, Inc.
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00264303
First received: December 8, 2005
Last updated: August 30, 2011
Last verified: June 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Chronic Idiopathic Urticaria |
Drug: Levocetirizine Drug: Desloratadine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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) |
Resource links provided by NLM:
Further study details as provided by UCB, Inc.:
Primary Outcome Measures:
- Mean Pruritus Severity Score Over the First Week of Treatment [ Time Frame: over the first week of treatment ] [ Designated as safety issue: No ]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:
- Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment [ Time Frame: over the first week of treatment ] [ Designated as safety issue: No ]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.
- Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment [ Time Frame: over the four weeks of treatment ] [ Designated as safety issue: No ]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.
- Mean Pruritus Severity Score Over the Four Weeks of Treatment [ Time Frame: over the four weeks of treatment ] [ Designated as safety issue: No ]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.
- Mean Score for Pruritus Duration Over the First Week of Treatment [ Time Frame: over the first week of treatment ] [ Designated as safety issue: No ]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.
- Mean Score for Pruritus Duration Over the Four Weeks of Treatment [ Time Frame: over the four weeks of treatment ] [ Designated as safety issue: No ]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.
| Enrollment: | 886 |
| Study Start Date: | December 2005 |
| Study Completion Date: | January 2007 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00264303
Show 80 Study Locations
Show 80 Study LocationsSponsors and Collaborators
UCB, Inc.
Investigators
| Study Director: | UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) |
More Information
Additional Information:
No publications provided
| Responsible Party: | UCB, Inc. |
| ClinicalTrials.gov Identifier: | NCT00264303 History of Changes |
| Other Study ID Numbers: | A00394, EudraCT 2005-000358-65, CUTE |
| Study First Received: | December 8, 2005 |
| Results First Received: | May 18, 2009 |
| Last Updated: | August 30, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products, FAMHP France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by UCB, Inc.:
|
Chronic Idiopathic Urticaria CUTE Levocetirizine Xyzal® |
Additional relevant MeSH terms:
|
Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Desloratadine Loratadine Levocetirizine Cetirizine Cholinergic Antagonists Cholinergic Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Antipruritics Dermatologic Agents Therapeutic Uses Anti-Allergic Agents |
ClinicalTrials.gov processed this record on June 17, 2013