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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
886
5mg oral capsules, once daily, 4 week duration
5mg oral capsules, once daily, 4 week duration
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.
Time frame: over the first week of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Bruges, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Liège, Belgium
Unnamed facility
Merksem, Belgium
Unnamed facility
Sint-Niklaas, Belgium
Unnamed facility
Woluwe-St-Lamb, Belgium
Unnamed facility
Bernay, France
Unnamed facility
Besançon, France
Unnamed facility
Hyères, France
Unnamed facility
Les Milles, France
...and 70 more locations
Time frame: 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.
Time frame: over the four weeks of treatment