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 | 10009159 |
E.1.2 | Term | Chronic urticaria |
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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 | 10009159 |
E.1.2 | Term | Chronic 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 |
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. |
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E.2.2 | Secondary objectives of the trial |
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography. Reduction in size of existing spontaneous urticaria lesions as assessed by volumetric analyses. Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by thermography. Reduction in size of new occuring spontaneous urticaria lesions (wheal and flare) as assessed by digital time lapse photography. Reduction in size of new occuring spontaneous urticaria lesions as assessed by volumetric analyses. Reduction of urticaria symptoms.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch. 2. Patients must exhibit spontaneous urticaria lesions at the randomization visit. 3. History of beneficial effects of antihistaminic treatment. 4. Age between 18 and 75 years. 5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised. 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. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed. 6. Voluntarily signed written informed consent.
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E.4 | Principal exclusion criteria |
1. The presence of permanent severe diseases, especially those affecting the immune system, except CU. 2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract). 3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia. 4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy. 5. Evidence of severe renal dysfunction 6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value). 7. The presence of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption. 8. History of adverse reactions including hypersensitivity to DL and Loratadine. 9. Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org). 10. Presence of active cancer which requires chemotherapy or radiation therapy. 11. Presence of acute urticaria / angioedema including laryngeal edema 12. History or presence of alcohol abuse or drug addiction. 13. Participation in any clinical trial within 4 weeks prior to enrolment. 14. Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study. 15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study. 16. Pregnancy or breast-feeding. 17. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
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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 20 mg Desloratadine (DL) is more effective in reducing the size, distribution and kinetics of urticaria lesions (wheal and flare) than 5 mg DL. The primary efficacy parameter of the study is the assessment of the reduction in size of urticaria lesions (wheal and flare) by thermography (within a defined area and period of time). |
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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 | 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) | 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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |