Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marcus Maurer
• Collaborator: Johannes Gutenberg University Mainz
• Treatments: Desloratadine; Loratadine

Criteria

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

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