CUTE (Chronic Urticaria Treatment Evaluation) - Full Text View

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT00264303

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 IV

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:

MedlinePlus related topics: Hives Itching

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

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

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

Additional Information:

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

Product Information This link exits the ClinicalTrials.gov site

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: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; 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 February 12, 2012