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Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU) (AUD2OCU)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00598611
First Posted: January 22, 2008
Last Update Posted: May 31, 2012
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.
Collaborator:
Essex Pharma GmbH
Information provided by (Responsible Party):
K. Weller, Charite University, Berlin, Germany
  Purpose
The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).

Condition Intervention Phase
Chronic Urticaria Drug: desloratadine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Phase III, Randomised, Double-blind, Therapeutic Single Dose-related Effect, Parallel Group Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. [ Time Frame: 5 hours ]

Secondary Outcome Measures:
  • Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by volumetry and digital time lapse photography. [ Time Frame: 5 hours ]

Enrollment: 29
Study Start Date: September 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
desloratadine 20 mg
Drug: desloratadine
singel dose, oral, 20 mg
Active Comparator: 2
desloratadine 20 mg
Drug: desloratadine
single dose, oral, 5 mg

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
  2. Patients must exhibit spontaneous urticaria lesions in the randomization visit.
  3. History of beneficial effects of antihistaminic treatment.
  4. Age between 18 and 60 years.
  5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
  6. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
  7. Voluntarily signed written informed consent.

Exclusion Criteria:

  1. The presence of permanent severe diseases, especially those affecting the immune system, except CU.
  2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the 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. The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
  8. History of adverse reactions including hypersensitivity to DL and Loratadine.
  9. Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
  10. Presence of active cancer which requires chemotherapy or radiation therapy.
  11. Presence of acute urticaria / angioedema including laryngeal edema
  12. History or presence of alcohol abuse or drug addiction.
  13. Participation in any clinical trial within 4 weeks prior to enrolment.
  14. Intake of oral corticosteroids or other immunosuppressive therapy 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.
  17. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00598611


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: K. Weller, Dr. Karsten Weller, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00598611     History of Changes
Other Study ID Numbers: P04805-V2.0
EudraCT number: 2006-003686-13
First Submitted: January 10, 2008
First Posted: January 22, 2008
Last Update Posted: May 31, 2012
Last Verified: May 2012

Keywords provided by K. Weller, Charite University, Berlin, Germany:
urticaria

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Desloratadine
Loratadine
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
Antipruritics
Dermatologic Agents
Anti-Allergic Agents