The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
NCT ID: NCT00346606
Last Updated: 2006-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
60 participants
INTERVENTIONAL
2006-01-31
Brief Summary
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Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary end point: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Detailed Description
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Trial design: Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
Primary endpoint: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries during the first two weeks of the treatment.
Secondary Objectives: To assess the efficacy and safety of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of subjects with CIU over 6 weeks.
Primary endpoint:
To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the patient diaries during the first two weeks of treatment
Secondary Endpoints- To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects' diaries over the 6 weeks.
To evaluate the reflective average AM/PM scores for number of hives, size of largest hive, and total symptom score (sum of pruritus, number of hives, and size of largest hive scores).
Average individual AM/PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
AM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM instantaneous scores for pruritus, number of hives, and size of largest hive are also evaluated.
PM reflective scores for pruritus, number of hives, and size of largest hive are also evaluated.
The interference with sleep (AM reflective), and interference with daily activities (PM reflective) are other secondary efficacy outcomes.
Therapeutic response will be evaluated at visit 3\~5.
Safety will be evaluated including vital signs are recorded at all visits, whereas sleep latency using Epworth Sleepiness Scale (ESS) questionnaire and Visual analogue Scale (VAS) are scored at visit 2\~5. Stanford Sleepiness Scale (SSS) are scored according to the instructions of diary cards at all visits. All adverse events are recorded and graded for severity at visit 2\~5.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Denosin® and Xyzal®
Eligibility Criteria
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Inclusion Criteria
* The subject ≥ 12 years old.
* The subject with documented signs and symptoms of CIU for 6 weeks or more.
* The subject has to have a CIU flare for 3 weeks or more before screening, with urticarial lesions visible 3 days or more per week.
* The overall severities of CIU have to be at least mild to moderate at screening and baseline, subjects have to have at least mild to moderate pruritus, hives have to be apparent at screening, and subjects have intention to treatment.
Exclusion Criteria
* The subject has received any other investigational drug within one month preceding randomization.
* The subject has previous non-response to antihistamines.
* The subject has previous allergy or allergies of desloratadine or levocetirizine.
* The subject need for long-term corticosteroids treatment (including inhaled, oral and topical dosage).
* The subject has autoimmune diseases.
* The subject's urticaria is physical urticaria, cholinergic urticaria or angioedema.
* The subject is in the situation of pregnancy or breastfeeding.
* The subject has liver dysfunction (AST ≧ 3 times normal range; ALT ≧ 3 times normal range ) or renal dysfunction (Creatinine ≧ 3.0mg/dl ).
* The subject is unable to keep an accurate diary of disease symptoms.
* The subject has significant concomitant illness, which, in the opinion of the investigator, will interfere with the evaluation of the study medications.
12 Years
ALL
No
Sponsors
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Lotus Pharmaceutical
INDUSTRY
Principal Investigators
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Jia-Yu Chu
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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Department of Dermatology National Taiwan University Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Jia-Yu Chu
Role: primary
Other Identifiers
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187CL1
Identifier Type: -
Identifier Source: org_study_id