Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU) (AUD2OCU)
This study has been completed.
Essex Pharma GmbH
Information provided by (Responsible Party):
K. Weller, Charite University, Berlin, Germany
First received: January 10, 2008
Last updated: May 30, 2012
Last verified: May 2012
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).
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
||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)
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2009 (Final data collection date for primary outcome measure)
Active Comparator: 1
desloratadine 20 mg
singel dose, oral, 20 mg
Active Comparator: 2
desloratadine 20 mg
single dose, oral, 5 mg
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Patients must exhibit spontaneous urticaria lesions in the randomization visit.
- History of beneficial effects of antihistaminic treatment.
- Age between 18 and 60 years.
- 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).
- Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
- Voluntarily signed written informed consent.
- The presence of permanent severe diseases, especially those affecting the immune system, except CU.
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the gastrointestinal tract).
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia.
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy.
- Evidence of severe renal dysfunction
- Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
- The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
- History of adverse reactions including hypersensitivity to DL and Loratadine.
- Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
- Presence of active cancer which requires chemotherapy or radiation therapy.
- Presence of acute urticaria / angioedema including laryngeal edema
- History or presence of alcohol abuse or drug addiction.
- Participation in any clinical trial within 4 weeks prior to enrolment.
- Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
- Pregnancy or breast-feeding.
- Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598611
|Berlin, Germany, 10117 |
Charite University, Berlin, Germany
Essex Pharma GmbH
||Marcus Maurer, MD
No publications provided
||K. Weller, Dr. Karsten Weller, Charite University, Berlin, Germany
History of Changes
|Other Study ID Numbers:
||P04805-V2.0, EudraCT number: 2006-003686-13
|Study First Received:
||January 10, 2008
||May 30, 2012
||Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Charite University, Berlin, Germany:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 19, 2013
Skin Diseases, Vascular
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists