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Trial record 1 of 1 for:    NCT00264303
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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double;   Primary Purpose: Treatment
Condition Chronic Idiopathic Urticaria
Interventions Drug: Levocetirizine
Drug: Desloratadine
Enrollment 886
Recruitment Details  
Pre-assignment Details 976 patients have been screened for this study. Ninety patients were ineligible for randomization, 886 have been randomized and treated. Participants flow and Baseline Characteristics refer to all patients randomized and treated.
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description Levocetirizine 5 mg once daily for four weeks Desloratadine 5 mg once daily for four weeks
Period Title: Overall Study
Started 438 448
Completed 413 419
Not Completed 25 29
Reason Not Completed
Adverse Event             4             3
Lack of Efficacy             10             13
Lost to Follow-up             3             3
Withdrawal by Subject             2             3
Various reasons listed in study report             6             7
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg Total
Hide Arm/Group Description Levocetirizine 5 mg once daily for four weeks Desloratadine 5 mg once daily for four weeks Total of all reporting groups
Overall Number of Baseline Participants 438 448 886
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 438 participants 448 participants 886 participants
43.4  (15.3) 42.9  (14.9) 43.1  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 438 participants 448 participants 886 participants
Female
284
  64.8%
306
  68.3%
590
  66.6%
Male
154
  35.2%
142
  31.7%
296
  33.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 438 participants 448 participants 886 participants
France 79 82 161
Malaysia 45 44 89
Spain 38 37 75
Belgium 14 10 24
Romania 57 56 113
South Africa 30 30 60
Germany 109 115 224
Italy 62 65 127
United Kingdom 4 9 13
1.Primary Outcome
Title Mean Pruritus Severity Score Over the First Week of Treatment
Hide Description 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.
Time Frame over the first week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 443
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.02  (0.04) 1.18  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments The primary hypothesis to be tested in this study was that the clinical efficacy of Levocetirizine 5 mg is superior to that of Desloratidine 5 mg
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled center as factors and baseline severity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Confidence Interval 95%
0.07 to 0.26
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
Hide Description 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.
Time Frame over the first week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 443
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.98  (0.08) 2.23  (0.08)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.25
Confidence Interval 95%
0.08 to 0.43
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
Hide Description 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.
Time Frame over the four weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 443
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.71  (0.07) 1.88  (0.07)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.041
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled center as factors and baseline CIU composite score as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Confidence Interval 95%
0.01 to 0.34
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Mean Pruritus Severity Score Over the Four Weeks of Treatment
Hide Description 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.
Time Frame over the four weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 443
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.86  (0.04) 0.99  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled center as factors and baseline pruritus severity score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.13
Confidence Interval 95%
0.04 to 0.22
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Score for Pruritus Duration Over the First Week of Treatment
Hide Description 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.
Time Frame over the first week of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 443
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
1.08  (0.04) 1.24  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled center as factors and baseline pruritus duration as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.16
Confidence Interval 95%
0.06 to 0.26
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Mean Score for Pruritus Duration Over the Four Weeks of Treatment
Hide Description 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.
Time Frame over the four weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) Population
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description:
Levocetirizine 5 mg once daily for four weeks
Desloratadine 5 mg once daily for four weeks
Overall Number of Participants Analyzed 434 444
Least Squares Mean (Standard Error)
Unit of Measure: Units on a scale
0.93  (0.04) 1.05  (0.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine 5 mg, Desloratadine 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment and pooled centers as factors and baseline pruritus duration score as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.12
Confidence Interval 95%
0.03 to 0.22
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levocetirizine 5 mg Desloratadine 5 mg
Hide Arm/Group Description Levocetirizine 5 mg once daily for four weeks Desloratadine 5 mg once daily for four weeks
All-Cause Mortality
Levocetirizine 5 mg Desloratadine 5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Levocetirizine 5 mg Desloratadine 5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/438 (0.00%)      2/448 (0.45%)    
Cardiac disorders     
Myocardial Infarction * 1  0/438 (0.00%)  0 1/448 (0.22%)  1
Metabolism and nutrition disorders     
Diabetes Imbalance * 1  0/438 (0.00%)  0 1/448 (0.22%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Levocetirizine 5 mg Desloratadine 5 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   80/438 (18.26%)      77/448 (17.19%)    
Gastrointestinal disorders     
Abdominal pain upper * 1  10/438 (2.28%)  11/448 (2.46%) 
Nausea * 1  5/438 (1.14%)  10/448 (2.23%) 
General disorders     
Fatigue * 1  19/438 (4.34%)  14/448 (3.13%) 
Nervous system disorders     
Headache * 1  35/438 (7.99%)  48/448 (10.71%) 
Somnolence * 1  31/438 (7.08%)  14/448 (3.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: +1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00264303    
Other Study ID Numbers: A00394
EudraCT 2005-000358-65
CUTE
First Submitted: December 8, 2005
First Posted: December 12, 2005
Results First Submitted: May 18, 2009
Results First Posted: July 9, 2009
Last Update Posted: August 31, 2011