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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: desloratadine
  • single dose for 7 days, oral, 20mg
• Drug: desloratadine
  • single dose for 7 days, oral, 5 mg
• Drug: placebo
  • single dose for 7 days, oral

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • desloratadine 20 mg
• Active Comparator: 2
  • desloratadine 5 mg
• Placebo Comparator: 3

Primary 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
    Safety Issue?: No

Secondary Measures

• Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
  • Time Frame: 15 minutes
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 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-Charité  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00600847

Study ID Number: P04685

ClinicalTrials.gov Identifier: NCT00600847

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