CUTE (Chronic Urticaria Treatment Evaluation)

• Sponsor: UCB Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00264303
• Collaborator: (none)
• Enrollment: 886
• Locations: 80
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 11.1
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Idiopathic Urticaria	Drug: Levocetirizine; Drug: Desloratadine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 886 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• 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)
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jan 1, 2007
• Actual Study Completion Date: Jan 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Mean Pruritus Severity Score Over the First Week of Treatment [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 Outcome Measures

1. Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Brugge		Belgium
2		Brussels		Belgium
3		Liege		Belgium
4		Merksem		Belgium
5		Sint-Niklaas		Belgium
6		Woluwe-St-Lamb		Belgium
7		Bernay		France
8		Besancon		France
9		Hyeres		France
10		Les Milles		France
11		Marseille		France
12		Montpellier		France
13		Nancy		France
14		Nantes		France
15		Nice		France
16		Nimes		France
17		Paris		France
18		Poitiers		France
19		Quimper		France
20		Saint-Mande		France
21		Troyes		France
22		Valence		France
23		Villejuif		France
24		Augsburg		Germany
25		Berlin		Germany
26		Dresden		Germany
27		Dusseldorf		Germany
28		Erlangen		Germany
29		Gottingen		Germany
30		Hamburg		Germany
31		Hannover		Germany
32		Koln		Germany
33		Leipzig		Germany
34		Mahlow		Germany
35		Mainz		Germany
36		Munchen		Germany
37		Viersen		Germany
38		Caserta		Italy
39		Catania		Italy
40		Cesena		Italy
41		Genova		Italy
42		Modena		Italy
43		Palermo		Italy
44		Pavia		Italy
45		Roma		Italy
46		Siena		Italy
47		Udine		Italy
48		Verona		Italy
49		Johor Bharu		Malaysia
50		Kelantan		Malaysia
51		Kuala Lumpur		Malaysia
52		Negeri Sembilan		Malaysia
53		Perak		Malaysia
54		Pulau Pinang		Malaysia
55		Sarawak		Malaysia
56		Brasov		Romania
57		Bucharest		Romania
58		Dolj		Romania
59		Sibiu		Romania
60		Cape Town		South Africa
61		Durban		South Africa
62		Lenasia		South Africa
63		Albacete		Spain
64		Barcelona		Spain
65		Coruna		Spain
66		Granada		Spain
67		Madrid		Spain
68		Malaga		Spain
69		Murcia (El Palmar)		Spain
70		Oviedo		Spain
71		Santiago de Compostela		Spain
72		Sevila		Spain
73		Valencia		Spain
74		Amersham		United Kingdom
75		Cardiff		United Kingdom
76		Irvine		United Kingdom
77		Leicester		United Kingdom
78		London		United Kingdom
79		Nuneaton		United Kingdom
80		Salford		United Kingdom

Sponsors and Collaborators

• UCB Pharma

Investigators

• Study Director: UCB Clinical Trial Call Center, [phone] (UCB)

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: UCB Pharma
• ClinicalTrials.gov Identifier: NCT00264303
• Other Study ID Numbers: A00394; EudraCT 2005-000358-65; CUTE
• First Posted: Dec 12, 2005
• Last Update Posted: Aug 31, 2011
• Last Verified: Jun 1, 2011

• Keywords provided by UCB Pharma: Chronic Idiopathic Urticaria; CUTE Levocetirizine Xyzal®
• Additional relevant MeSH terms: Urticaria; Chronic Urticaria; Levocetirizine; Desloratadine

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg	Total
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 Participants	438	448	886
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.4 (15.3)	42.9 (14.9)	43.1 (15.1)
Sex: Female, Male (Count of Participants)
Female	284 64.8%	306 68.3%	590 66.6%
Male	154 35.2%	142 31.7%	296 33.4%
Region of Enrollment (participants) [Number]
France	79 18%	82 18.3%	161 18.2%
Malaysia	45 10.3%	44 9.8%	89 10%
Spain	38 8.7%	37 8.3%	75 8.5%
Belgium	14 3.2%	10 2.2%	24 2.7%
Romania	57 13%	56 12.5%	113 12.8%
South Africa	30 6.8%	30 6.7%	60 6.8%
Germany	109 24.9%	115 25.7%	224 25.3%
Italy	62 14.2%	65 14.5%	127 14.3%
United Kingdom	4 0.9%	9 2%	13 1.5%

Outcome Measures

1. Secondary Outcome

Title	Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the First Week of Treatment
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	443
Least Squares Mean (Standard Error) [Units on a scale]	1.98 (0.08)	2.23 (0.08)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levocetirizine 5 mg, Desloratadine 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Chronic Idiopathic Urticaria (CIU) Composite Score Over the Four Weeks of Treatment
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) Population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	443
Least Squares Mean (Standard Error) [Units on a scale]	1.71 (0.07)	1.88 (0.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levocetirizine 5 mg, Desloratadine 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.041
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean Pruritus Severity Score Over the Four Weeks of Treatment
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) Population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	443
Least Squares Mean (Standard Error) [Units on a scale]	0.86 (0.04)	0.99 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levocetirizine 5 mg, Desloratadine 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Mean Score for Pruritus Duration Over the First Week of Treatment
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) Population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	443
Least Squares Mean (Standard Error) [Units on a scale]	1.08 (0.04)	1.24 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levocetirizine 5 mg, Desloratadine 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Mean Score for Pruritus Duration Over the Four Weeks of Treatment
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

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) Population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	444
Least Squares Mean (Standard Error) [Units on a scale]	0.93 (0.04)	1.05 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Levocetirizine 5 mg, Desloratadine 5 mg
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Mean Pruritus Severity Score Over the First Week of Treatment
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

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	Levocetirizine 5 mg	Desloratadine 5 mg
Arm/Group Description	Levocetirizine 5 mg once daily for four weeks	Desloratadine 5 mg once daily for four weeks
Measure Participants	434	443
Least Squares Mean (Standard Error) [Units on a scale]	1.02 (0.04)	1.18 (0.04)

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
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Levocetirizine 5 mg		Desloratadine 5 mg
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Levocetirizine 5 mg		Desloratadine 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/438 (0%)		2/448 (0.4%)
Cardiac disorders
Myocardial Infarction	0/438 (0%)	0	1/448 (0.2%)	1
Metabolism and nutrition disorders
Diabetes Imbalance	0/438 (0%)	0	1/448 (0.2%)	1
Other (Not Including Serious) Adverse Events
	Levocetirizine 5 mg		Desloratadine 5 mg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	80/438 (18.3%)		77/448 (17.2%)
Gastrointestinal disorders
Abdominal pain upper	10/438 (2.3%)		11/448 (2.5%)
Nausea	5/438 (1.1%)		10/448 (2.2%)
General disorders
Fatigue	19/438 (4.3%)		14/448 (3.1%)
Nervous system disorders
Headache	35/438 (8%)		48/448 (10.7%)
Somnolence	31/438 (7.1%)		14/448 (3.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.