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

Urticaria Clinical Trial

— AECUDATT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01444196
• Other study ID #: 2008-005746-22
• Secondary ID: 2008-005746-22
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2011
• Last updated: September 30, 2011
• Start date: August 2009
• Est. completion date: May 2010

Study information

• Verified date: September 2011
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urticaria

Intervention

Drug:
• Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.

Locations

Country	Name	City	State
Germany	Department of Dermatology, Venerology and Allergology	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Marcus Maurer	Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs		6 weeks	Yes
Secondary	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	Yes

External Links

•   Kälteurtikaria