Chronic Idiopathic Urticaria | The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria
Chronic Idiopathic Urticaria research study
What is the primary objective of this study?
Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks. 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.
Who is eligible to participate?
Inclusion Criteria: - The subject or deputy has read or been informed and signed the Informed Consent Agreement and the subject will be willing and able to participate in the study. - 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 histamine, corticosteroids, ketotifene, systemic antibiotics, nedocromil, sodium cromoglycate or thyroxin drug within 7 days preceding randomization. - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Chronic Idiopathic Urticaria
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Denosin® and Xyzal®
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2006
Phase: Phase 4
Primary Outcome: 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 Outcome: To evaluate the change in average AM/PM reflective pruritus score from baseline recorded in the subjects’ diaries over the 6 weeks.
Study sponsors, principal investigator, and references
Principal Investigator: Jia-Yu Chu
Lead Sponsor: Lotus Pharmaceutical