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

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

Detailed Description
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A total of 30 patients (male and female) with ACU will be included in this study

Official Title
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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)

Conditions
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Urticaria

Intervention / Treatment
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* Drug: Desloratadine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Desloratadine dose<br>Study group: 5 mg Desloratadine during the whole study 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. | Drug: Desloratadine<br>* Every day,per mouth,in the evening, for 14 +- 2 days.<br>* Other names: No arm names.;|
| Other: Dose of Desloratadine<br>Study group: 5 mg Desloratadine during the whole study 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. | Drug: Desloratadine<br>* Every day,per mouth,in the evening, for 14 +- 2 days.<br>* Other names: No arm names.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI) |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACU, acquired cold urticaria