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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00600847
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : January 25, 2008
Information provided by:
Charite University, Berlin, Germany

Brief Summary:
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 or disease Intervention/treatment Phase
Acquired Cold Urticaria Drug: desloratadine Drug: placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : November 2006
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hives

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. [ Time Frame: 15 minutes ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00600847

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

Additional Information:
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Responsible Party: Marcus Maurer, MD, Allergie-Centrum-Charité Identifier: NCT00600847     History of Changes
Other Study ID Numbers: P04685
EudraCT-Number: 2005-006133-32
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: January 25, 2008
Last Verified: January 2008

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

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