E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Idiopathic Urticaria |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009159 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 violated, a non-parametric approach will be used. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date of database lock as, at the time, interactions between the Sponsor and the Investigator(s) with possible impact on subject’s data have ended. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 8 |