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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:
Collaborator:
Essex Pharma GmbH
Information provided by (Responsible Party):
K. Weller, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00598611
First received: January 10, 2008
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: Hives
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

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
Study First Received: January 10, 2008
Last Updated: May 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by 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
Pharmacologic Actions
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Antipruritics
Dermatologic Agents
Therapeutic Uses
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 19, 2013