E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009869 |
E.1.2 | Term | Cold urticaria |
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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 |
The main objective of the study is the assessment of wheal development before and after treatment with study medication. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to assess the effects of DL 5, (10, and 20) mg in reducing disease activity measured by critical temperature threshold (CTTs) and critical stimulation time threshold (CSTT) in ACU patients. CTTs and CSTT will be assessed using TEMPtest 3.0, a novel and validated instrument for measuring TTs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Informed consent signed and dated • Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner • Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. • Age between 18 and 75 years.
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E.4 | Principal exclusion criteria |
• Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz). • The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria • The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) • History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia • History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy • Evidence of severe renal dysfunction • Evidence of significant hepatic disease (liver enzymes twice the upper reference value) • History of adverse reactions to DL • Presence of active cancer which requires chemotherapy or radiation therapy • Presence of alcohol abuse or drug addiction • Intake of oral corticosteroids within 14 days prior to screening visit • Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit • Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit. • Pregnancy or breast-feeding
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E.5 End points |
E.5.1 | Primary end point(s) |
The main goal of the analysis is to test whether treatment with 5, 10 or 20 mg Desloratadine (DL) is effective to inhibit cold urticaria lesions. |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
randomized dose escalation |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
5 mg vs. 20 mg Desloratadine |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | Yes |
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 last visit of the last patient is defined as the end of the trial. |
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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 | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 11 |