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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2005-000358-65 | |||
| CUTE |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levocetirizine | Experimental | Levocetirizine, once daily, 4 week duration |
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| Desloratadine | Active Comparator | Desloratadine, once daily, 4 week duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levocetirizine | Drug | 5mg oral capsules, once daily, 4 week duration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pruritus Severity Score 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. | over the first week of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bruges | Belgium | |||||
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| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Levocetirizine 5 mg | Levocetirizine 5 mg once daily for four weeks |
| FG001 | Desloratadine 5 mg | Desloratadine 5 mg once daily for four weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Desloratadine |
| Drug |
5mg oral capsules, once daily, 4 week duration |
|
| over the first week of treatment |
| Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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. | over the four weeks of treatment |
| Mean Pruritus Severity Score 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. | over the four weeks of treatment |
| Mean Score for Pruritus Duration 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. | over the first week of treatment |
| Mean Score for Pruritus Duration 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. | over the four weeks of treatment |
| Brussels |
| Belgium |
| Liège | Belgium |
| Merksem | Belgium |
| Sint-Niklaas | Belgium |
| Woluwe-St-Lamb | Belgium |
| Bernay | France |
| Besançon | France |
| Hyères | France |
| Les Milles | France |
| Marseille | France |
| Montpellier | France |
| Nancy | France |
| Nantes | France |
| Nice | France |
| Nîmes | France |
| Paris | France |
| Poitiers | France |
| Quimper | France |
| Saint-Mandé | France |
| Troyes | France |
| Valence | France |
| Villejuif | France |
| Augsburg | Germany |
| Berlin | Germany |
| Cologne | Germany |
| Dresden | Germany |
| Düsseldorf | Germany |
| Erlangen | Germany |
| Göttingen | Germany |
| Hamburg | Germany |
| Hanover | Germany |
| Leipzig | Germany |
| Mahlow | Germany |
| Mainz | Germany |
| München | Germany |
| Viersen | Germany |
| Caserta | Italy |
| Catania | Italy |
| Cesena | Italy |
| Genova | Italy |
| Modena | Italy |
| Palermo | Italy |
| Pavia | Italy |
| Roma | Italy |
| Siena | Italy |
| Udine | Italy |
| Verona | Italy |
| Johor Bharu | Malaysia |
| Kelantan | Malaysia |
| Kuala Lumpur | Malaysia |
| Negeri Sembilan | Malaysia |
| Perak | Malaysia |
| Pulau Pinang | Malaysia |
| Sarawak | Malaysia |
| Brasov | Romania |
| Bucharest | Romania |
| Dolj | Romania |
| Sibiu | Romania |
| Cape Town | South Africa |
| Durban | South Africa |
| Lenasia | South Africa |
| A Coruña | Spain |
| Albacete | Spain |
| Barcelona | Spain |
| Granada | Spain |
| Madrid | Spain |
| Málaga | Spain |
| Murcia (El Palmar) | Spain |
| Oviedo | Spain |
| Santiago de Compostela | Spain |
| Seville | Spain |
| Valencia | Spain |
| Amersham | United Kingdom |
| Cardiff | United Kingdom |
| Irvine | United Kingdom |
| Leicester | United Kingdom |
| London | United Kingdom |
| Nuneaton | United Kingdom |
| Salford | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Levocetirizine 5 mg | Levocetirizine 5 mg once daily for four weeks |
| BG001 | Desloratadine 5 mg | Desloratadine 5 mg once daily for four weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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. | Intent to treat (ITT) population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the first week of treatment |
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| Secondary | Mean Chronic Idiopathic Urticaria (CIU) Composite Score 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. | Intent to treat (ITT) Population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the four weeks of treatment |
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| Secondary | Mean Pruritus Severity Score 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. | Intent to treat (ITT) Population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the four weeks of treatment |
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| Secondary | Mean Score for Pruritus Duration 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. | Intent to treat (ITT) Population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the first week of treatment |
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| Secondary | Mean Score for Pruritus Duration 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. | Intent to treat (ITT) Population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the four weeks of treatment |
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| Primary | Mean Pruritus Severity Score 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. | ITT population | Posted | Least Squares Mean | Standard Error | Units on a scale | over the first week of treatment |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Levocetirizine 5 mg | Levocetirizine 5 mg once daily for four weeks | 0 | 438 | 80 | 438 | ||
| EG001 | Desloratadine 5 mg | Desloratadine 5 mg once daily for four weeks | 2 | 448 | 77 | 448 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes Imbalance | Metabolism and nutrition disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 9.0 | Non-systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| UCB Clinical Trial Call Center | UCB Pharma | +1 877 822 9493 |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C472067 | levocetirizine |
| C121345 | desloratadine |
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| Male |
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| Malaysia |
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| Spain |
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| Belgium |
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| Romania |
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| South Africa |
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| Germany |
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| Italy |
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| United Kingdom |
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