Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
NCT ID: NCT01444196
Last Updated: 2011-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2009-08-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Desloratadine dose
1. Study group: 5 mg Desloratadine during the whole study
2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.
Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Dose of Desloratadine
1. Study group: 5 mg Desloratadine during the whole study
2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4.
Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Interventions
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Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Johannes Gutenberg University Mainz
OTHER
Marcus Maurer
OTHER
Responsible Party
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Marcus Maurer
Head of Research Dept. of Dermatology
Principal Investigators
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Marcus Maurer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Charite, University
Locations
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Department of Dermatology, Venerology and Allergology
Berlin, State of Berlin, Germany
Countries
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Related Links
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Kälteurtikaria
Other Identifiers
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2008-005746-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2008-005746-22
Identifier Type: -
Identifier Source: org_study_id