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

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: August 2009

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

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

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

Participating in This Clinical Trial

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: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Collaborator
    • Essex Pharma GmbH
  • Provider of Information About this Clinical Study
    • Principal Investigator: K. Weller, Dr. Karsten Weller – Charite University, Berlin, Germany
  • Overall Official(s)
    • Marcus Maurer, MD, Principal Investigator, Allergie-Centrum-Charite

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