Trial Outcomes & Findings for CUTE (Chronic Urticaria Treatment Evaluation) (NCT NCT00264303)
NCT ID: NCT00264303
Last Updated: 2011-08-31
Results Overview
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.
COMPLETED
PHASE4
886 participants
over the first week of treatment
2011-08-31
Participant Flow
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.
Participant milestones
| Measure |
Levocetirizine 5 mg
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Overall Study
STARTED
|
438
|
448
|
|
Overall Study
COMPLETED
|
413
|
419
|
|
Overall Study
NOT COMPLETED
|
25
|
29
|
Reasons for withdrawal
| Measure |
Levocetirizine 5 mg
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lack of Efficacy
|
10
|
13
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Various reasons listed in study report
|
6
|
7
|
Baseline Characteristics
CUTE (Chronic Urticaria Treatment Evaluation)
Baseline characteristics by cohort
| Measure |
Levocetirizine 5 mg
n=438 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=448 Participants
Desloratadine 5 mg once daily for four weeks
|
Total
n=886 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
43.4 years
STANDARD_DEVIATION 15.3 • n=5 Participants
|
42.9 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
43.1 years
STANDARD_DEVIATION 15.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
284 Participants
n=5 Participants
|
306 Participants
n=7 Participants
|
590 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
79 participants
n=5 Participants
|
82 participants
n=7 Participants
|
161 participants
n=5 Participants
|
|
Region of Enrollment
Malaysia
|
45 participants
n=5 Participants
|
44 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
38 participants
n=5 Participants
|
37 participants
n=7 Participants
|
75 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
14 participants
n=5 Participants
|
10 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
57 participants
n=5 Participants
|
56 participants
n=7 Participants
|
113 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
109 participants
n=5 Participants
|
115 participants
n=7 Participants
|
224 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
62 participants
n=5 Participants
|
65 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 participants
n=5 Participants
|
9 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: over the first week of treatmentPopulation: ITT population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=443 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Pruritus Severity Score Over the First Week of Treatment
|
1.02 Units on a scale
Standard Error 0.04
|
1.18 Units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: over the first week of treatmentPopulation: Intent to treat (ITT) population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=443 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
|
1.98 Units on a scale
Standard Error 0.08
|
2.23 Units on a scale
Standard Error 0.08
|
SECONDARY outcome
Timeframe: over the four weeks of treatmentPopulation: Intent to treat (ITT) Population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=443 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
|
1.71 Units on a scale
Standard Error 0.07
|
1.88 Units on a scale
Standard Error 0.07
|
SECONDARY outcome
Timeframe: over the four weeks of treatmentPopulation: Intent to treat (ITT) Population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=443 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Pruritus Severity Score Over the Four Weeks of Treatment
|
0.86 Units on a scale
Standard Error 0.04
|
0.99 Units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: over the first week of treatmentPopulation: Intent to treat (ITT) Population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=443 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Score for Pruritus Duration Over the First Week of Treatment
|
1.08 Units on a scale
Standard Error 0.04
|
1.24 Units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: over the four weeks of treatmentPopulation: Intent to treat (ITT) Population
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.
Outcome measures
| Measure |
Levocetirizine 5 mg
n=434 Participants
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=444 Participants
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Mean Score for Pruritus Duration Over the Four Weeks of Treatment
|
0.93 Units on a scale
Standard Error 0.04
|
1.05 Units on a scale
Standard Error 0.04
|
Adverse Events
Levocetirizine 5 mg
Desloratadine 5 mg
Serious adverse events
| Measure |
Levocetirizine 5 mg
n=438 participants at risk
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=448 participants at risk
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes Imbalance
|
0.00%
0/438
|
0.22%
1/448 • Number of events 1
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/438
|
0.22%
1/448 • Number of events 1
|
Other adverse events
| Measure |
Levocetirizine 5 mg
n=438 participants at risk
Levocetirizine 5 mg once daily for four weeks
|
Desloratadine 5 mg
n=448 participants at risk
Desloratadine 5 mg once daily for four weeks
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
10/438
|
2.5%
11/448
|
|
General disorders
Fatigue
|
4.3%
19/438
|
3.1%
14/448
|
|
Nervous system disorders
Headache
|
8.0%
35/438
|
10.7%
48/448
|
|
Gastrointestinal disorders
Nausea
|
1.1%
5/438
|
2.2%
10/448
|
|
Nervous system disorders
Somnolence
|
7.1%
31/438
|
3.1%
14/448
|
Additional Information
UCB Clinical Trial Call Center
UCB Pharma
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER