The primary objective of the study is to assess the dosis of DL which is sufficient to
inhibit cold urticaria symptoms.
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Locations near you
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Full eligibility criteria for NCT01444196
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01444196
Department of Dermatology, Venerology and Allergology
Berlin, Germany, 10117
View full eligibility
Tris trial is registered with FDA with number: NCT01444196. The sponsor of the trial is Marcus Maurer and it is looking for 30 volunteers for the current phase.
Official trial title: 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)
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