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

NCT01444196 | Completed Phase 4 DMC

• 1 other identifier: 2008-005746-22
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urticaria

Keywords

ACU; acquired cold urticaria

Outcome Measures

Primary Outcomes (1)

• CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs

  6 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

Desloratadine dose

OTHER

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.

Drug: Desloratadine

Dose of Desloratadine

OTHER

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.

Drug: Desloratadine

Interventions

Desloratadine DRUG

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

Also known as: No arm names.

Desloratadine dose; Dose of Desloratadine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marcus Maurer: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

Department of Dermatology, Venerology and Allergology

Berlin, State of Berlin, 10117, Germany

Location

Related Links

• Kälteurtikaria

MeSH Terms

Conditions

Urticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marcus Maurer, Prof.

  Charite, University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research Dept. of Dermatology

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: September 30, 2011
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: October 3, 2011

Record last verified: 2011-09

Locations

DE (1)