Multi-center, double blind, dose escalating study to compare the effects of 5 mg, 10mg and 20mg of Desloratadine in patients with acquired cold urticaria (ACU) - AECUDATT
- Conditions
- Chronic urticaria is characterized by the spontaneous development of wheal and flare type skin reactions.MedDRA version: 9.1Level: LLTClassification code 10009869Term: Cold urticaria
- Registration Number
- EUCTR2008-005746-22-DE
- Lead Sponsor
- Allergie-Centrum-Charite, Department of Dermatology, Charite - Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
•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.
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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the study is the assessment of wheal development before and after treatment with study medication. ;Secondary Objective: 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.;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.
- Secondary Outcome Measures
Name Time Method