A multicentre, double-blind, two parallel groups, randomized trial over four weeks oftreatment to compare the clinical efficacy and safety of Levocetirizine 5 mg oral capsules once daily in the morning vs. Desloratadine 5 mg oral capsules once daily in the morning in patients suffering from Chronic Idiopathic Urticaria (CIU)
- Conditions
- Chronic Idiopathic UrticariaMedDRA version: 8.0Level: LLTClassification code 10009159
- Registration Number
- EUCTR2005-000358-65-BE
- Lead Sponsor
- CB S.A. Pharma Sector
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 816
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method