Chronic Idiopathic Urticaria MedDRA version: 8.0 Level: LLT Classification code 10009159
Conditions
Interventions
Product Name: Levocetirizine
Pharmaceutical Form: Capsule*
INN or Proposed INN: Levocetirizine Dihydrochloride
CAS Number: 130018-87-0
Current Sponsor code: ucb 28556
Other descriptive name: (2(4-((R)
Sponsors
UCB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, all of the following criteria must be met at Visit 1(selection visit): ? Have been informed of the nature and aims of the study and have given their written informed consent signed and dated. ? Male or female patients 18 years or older. ? Female subjects of childbearing potential must agree not to become pregnant during thestudy. Female subjects are considered of non-childbearing potential before menarche,or at least two years after menopause, or if they had a total hysterectomy or a bilateral ovariectomy or a congenital sterility. When sexually active, females of childbearing potential must be using a medically accepted contraceptive method (hormonal birth control, per os, injectable or by implant, for at least 2 months), have had a bilateral tubal ligation, have monogamous relationship with vasectomized partner or agree to use intrauterine device, diaphragm with spermicide or male condom with spermicide. The female subject must understand the consequences and potential risks of inadequately protected sexual activity, be educated about and understand the proper use of contraceptive method, and undertake to inform the Investigator of any potential change in status. ? Clinical history of Chronic Idiopathic Urticaria (i.e. episodes of hives of characteristic wheal and flare appearance, occurring regularly, at least 3 times a week) for a period of at least 6 weeks during the last 3 months without an identifiable cause. ? Out-patients. ? Subjects considered as reliable and mentally capable of adhering to the protocol (i.e., completing the daily record card and questionnaires), according to the judgment of the Investigator. The subjects should meet the following criteria at Visit 2 (randomization visit): ? Female subjects with childbearing potential are eligible if they have a negative urinepregnancy test at Visit 2. ? During the one-week baseline period for at least 3 days: ? The pruritus severity (over the last 24 hours) has to be minimum 2 and ? The number of wheal score (at the moment of evaluation) has to be =1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects must be excluded if they meet any of the following criteria at Visit 1: ? Be incapable of giving their written informed consent. ? Pregnancy or breast feeding. ? Have any of the following pathologies: senile pruritus; acute urticaria; cholinergic, solar, heat, cold, water or drug-induced urticaria; isolated delayed pressure urticaria; contact urticaria; urticarial vasculitis; or hereditary angioneurotic oedema. ? Have any dermatological disease that would interfere with evaluation of therapeutic response (e.g. generalized psoriasis, atopic dermatitis, contact dermatitis...). ? Have a history of autoimmune disorders, Hodgkin’s disease, lymphoma, leukemia and generalized cancer. ? Presence of other clinically significant disease (cardiovascular, hepatic, renal, autoimmune or associated with hematology, neurology, psychiatry) or any other disease which would disturb absorption, distribution, metabolism or excretion of the investigational product. ? Subject intending to donate blood during the study. ? Have used the following medications within the specified wash-out periods (calculates in relation to V1) and during the course of the study: Astemizole 12 weeks Systemic and topical corticosteroids 4 weeks Ketotifen 2 weeks Loratadine, desloratadine 10 days Doxepin 10 days Other systemic antihistamines (H1 and H2) 3 days Leucotrienes antagonists (e.g.: montelukast) 3 days Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents: No wash out period Nonsteroidal anti-inflammatory drugs: No wash out period ? Be hypersensive to levocetirizine or its excipients, desloratadine or to any other piperazine derivatives such as hydroxyzine, cetirizine, cyclizine, meclozine or buclizine. ? Be expected non compliant with the investigational products or with the protocol requirements. ? Have a known lack of response to H1- antihistamines. ? Have a history of alcoholism, drug addiction or mental instability. ? Have participated in a clinical trial during the last three months before V1. Subjects must be excluded at Visit 2 if they meet any of the following criteria: ? Have a baseline period (Visit 1-Visit 2) inferior to three days or superior to nine days. ? No recording for at least three distinct days of presence of pruritus score > 2 and/or number of wheals score > 1. ? Have taken any prohibited medication during the baseline period. ? Have presented any of the exclusion criteria checked at Visit 1 during the baseline period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare clinical efficacy of levocetirizine 5 mg and desloratadine 5 mg as measured by the mean pruritus severity score over the first week of treatment. Pruritus severity will be evaluated on 4-point scale retrospectively over the past 24 hours.;Secondary Objective: ? To compare clinical efficacy of levocetirizine 5 mg and desloratadine 5 mg as measured by the mean CIU composite score (sum of the pruritus severity score and the score for the numbers of wheals) over the first and over the four weeks of treatment. ? To compare clinical efficacy of levocetirizine 5 mg and desloratadine 5 mg as measured by the mean pruritus severity score over four weeks of treatment. ? To compare clinical efficacy of levocetirizine 5 mg and desloratadine 5 mg as measured by the mean score for pruritus duration, number and size of wheals evaluated on 4-point scales retrospectively over the past 24 hours over the first and over the four weeks of treatment. ? To compare Global Satisfaction of the treatment with levocetirizine 5 mg and desloratadine 5 mg assessed by the patients and investigators on a VAS from 0 to 10 cm after the first and after the four weeks of treatment. ? Evaluation of the safety profile.;Primary end point(s): The primary hypothesis to be tested in this study is that the clinical efficacy of levocetirizine 5 mg is superior to that of desloratadine 5 mg. This hypothesis will be tested two-tailed at the 5% level of significance. The mean scores pruritus severity during the first week of treatment will be analyzed using an analysis of covariance (ANCOVA) model including treatment as factor with two levels (one for each treatment group), baseline score, and center. The treatment group difference will be estimated by the difference in least square (LS) means together with 95% CI. The test and p-value will be based on these estimated LS Means through a contrast between the treatment groups. If the normality assumption underlying ANCOVA appears to be viol | — |
Countries
Belgium, Italy, Spain, United Kingdom
Outcome results
None listed