Status:
COMPLETED
Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
Lead Sponsor:
Marcus Maurer
Collaborating Sponsors:
Johannes Gutenberg University Mainz
Conditions:
Urticaria
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.
Detailed Description
A total of 30 patients (male and female) with ACU will be included in this study
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01444196
Start Date
August 1 2009
End Date
May 1 2010
Last Update
October 3 2011
Active Locations (1)
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1
Department of Dermatology, Venerology and Allergology
Berlin, State of Berlin, Germany, 10117