A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions - Full Text View

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00600847

Purpose

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.

Condition	Intervention	Phase
Acquired Cold Urticaria	Drug: desloratadine Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
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

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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Enrollment:	33
Study Start Date:	November 2006
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 desloratadine 20 mg	Drug: desloratadine single dose for 7 days, oral, 20mg
Active Comparator: 2 desloratadine 5 mg	Drug: desloratadine single dose for 7 days, oral, 5 mg
Placebo Comparator: 3	Drug: placebo single dose for 7 days, oral

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
History of beneficial effects of antihistaminic treatment.
Age between 18 and 75 years.
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.
Voluntarily signed written informed consent.

Exclusion Criteria:

The presence of permanent severe diseases, especially those affecting the immune system, except ACU
The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of 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)
History of adverse reactions to DL, loratadine, or other ingredients of the IMP
Presence of active cancer which requires chemotherapy or radiation therapy
Presence of acute urticaria, angioedema, or larynx edema
History or presence of alcohol abuse or drug addiction
Participation in any clinical trial within 4 weeks prior to enrolment
Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
Intake of oral corticosteroids 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00600847

Locations

Germany
Allergie-Centrum-Charité Berlin
Berlin, Germany, 10117

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Marcus Maurer, MD

Allergie-Centrum-Charité

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Marcus Maurer, MD, Allergie-Centrum-Charité
ClinicalTrials.gov Identifier:	NCT00600847 History of Changes
Other Study ID Numbers:	P04685, EudraCT-Number: 2005-006133-32
Study First Received:	January 15, 2008
Last Updated:	January 15, 2008
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:

urticaria
cold urticaria
acquired cold 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 February 12, 2012