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

This study has been completed.
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01444196
First received: September 29, 2011
Last updated: September 30, 2011
Last verified: September 2011
  Purpose

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


Condition Intervention Phase
Urticaria
Drug: Desloratadine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: August 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Desloratadine dose
  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
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Name: No arm names.
Dose of Desloratadine
  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
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Name: No arm names.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444196

Locations
Germany
Department of Dermatology, Venerology and Allergology
Berlin, Germany, 10117
Sponsors and Collaborators
Marcus Maurer
Johannes Gutenberg University Mainz
Investigators
Principal Investigator: Marcus Maurer, Prof. Charite, University
  More Information

Additional Information:
No publications provided

Responsible Party: Marcus Maurer, Head of Research Dept. of Dermatology, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01444196     History of Changes
Other Study ID Numbers: 2008-005746-22, 2008-005746-22
Study First Received: September 29, 2011
Last Updated: September 30, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
ACU
acquired cold urticaria

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents

ClinicalTrials.gov processed this record on September 18, 2014