A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions (AUDACU)

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00600847
First received: January 15, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.


Condition Intervention Phase
Acquired Cold Urticaria
Drug: desloratadine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Phase IV, Randomised, Double-Blind, Placebo Controlled Crossover Study to Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Experimentally Induced Urticaria Lesions

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography. [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: November 2006
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
desloratadine 20 mg
Drug: desloratadine
single dose for 7 days, oral, 20mg
Active Comparator: 2
desloratadine 5 mg
Drug: desloratadine
single dose for 7 days, oral, 5 mg
Placebo Comparator: 3 Drug: placebo
single dose for 7 days, oral

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
  2. History of beneficial effects of antihistaminic treatment.
  3. Age between 18 and 75 years.
  4. Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised.
  5. Voluntarily signed written informed consent.

Exclusion Criteria:

  1. The presence of permanent severe diseases, especially those affecting the immune system, except ACU
  2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
  3. History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
  4. History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
  5. Evidence of severe renal dysfunction
  6. Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
  7. History of adverse reactions to DL, loratadine, or other ingredients of the IMP
  8. Presence of active cancer which requires chemotherapy or radiation therapy
  9. Presence of acute urticaria, angioedema, or larynx edema
  10. History or presence of alcohol abuse or drug addiction
  11. Participation in any clinical trial within 4 weeks prior to enrolment
  12. Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
  13. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
  14. Intake of oral corticosteroids within 14 days prior to the beginning of the study
  15. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
  16. 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: NCT00600847

Locations
Germany
Allergie-Centrum-Charité Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Marcus Maurer, MD Allergie-Centrum-Charité
  More Information

Additional Information:
No publications provided

Responsible Party: Marcus Maurer, MD, Allergie-Centrum-Charité
ClinicalTrials.gov Identifier: NCT00600847     History of Changes
Other Study ID Numbers: P04685, EudraCT-Number: 2005-006133-32
Study First Received: January 15, 2008
Last Updated: January 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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