Clinical trial NCT01444196: Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Urticaria
Keywords: ACU
acquired cold urticaria
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2011-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs
timeFrame: 6 weeks
Secondary outcomes:
measure: 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)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Dermatology, Venerology and Allergology
Study officials:
affiliation: Charite, University
name: Marcus Maurer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: