Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions. MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria MedDRA version: 9.1 Level: LLT Classification code 10009159 Term: Chronic urticaria
Conditions
Interventions
Trade Name: Aerius
Product Name: Desloratadine
Product Code: SCH34117
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: DESLORATADINE
CAS Number: 100643-71-8
Other descriptive name: Aerius
Sponsors
Allergie-Centrum-Charite, Department of Dermatology, Charite - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. ;Secondary Objective: 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. ;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). | — |
Countries
Germany
Outcome results
None listed