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

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)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01444196

Acronym

AECUDATT

Enrollment

Registered

2011-09-30

Start date

2009-08-31

Completion date

2010-05-31

Last updated

2011-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urticaria

Keywords

ACU, acquired cold urticaria

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

Interventions

DRUGDesloratadine

Every day,per mouth,in the evening, for 14 +- 2 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs	6 weeks

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026