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)”

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 effecient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Dose Comparison, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: desloratadine
  • singel dose, oral, 20 mg
• Drug: desloratadine
  • single dose, oral, 5 mg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • desloratadine 20 mg
• Active Comparator: 2
  • desloratadine 20 mg

Primary Measures

• Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography.
  • Time Frame: 5 hours
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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).

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Charite University, Berlin, Germany

Overall Clinical Trial Officials and Contacts

Marcus Maurer, MD Principal Investigator Allergie-Centrum-Charite  

Overall Contact: Marcus Maurer, MD 30-450-518042 marcus.maurer@charite.de

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00598611

Study ID Number: P04805-V2.0

ClinicalTrials.gov Identifier: NCT00598611

Health Authority: Germany: Federal Institute for Drugs and Medical Devices