Back to resultsA Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions (AUDACU)
Primary Purpose
Acquired Cold Urticaria
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
desloratadine
desloratadine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acquired Cold Urticaria focused on measuring urticaria, cold urticaria, acquired cold urticaria
Eligibility 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
Sites / Locations
- Allergie-Centrum-Charité Berlin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
desloratadine 20 mg
desloratadine 5 mg
Outcomes
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.
Secondary Outcome Measures
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
Full Information
NCT ID
NCT00600847
First Posted
January 15, 2008
Last Updated
January 15, 2008
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT00600847
Brief Title
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
Acronym
AUDACU
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Cold Urticaria
Keywords
urticaria, cold urticaria, acquired cold urticaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
desloratadine 20 mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
desloratadine 5 mg
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
desloratadine
Intervention Description
single dose for 7 days, oral, 20mg
Intervention Type
Drug
Intervention Name(s)
desloratadine
Intervention Description
single dose for 7 days, oral, 5 mg
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
single dose for 7 days, oral
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcus Maurer, MD
Organizational Affiliation
Allergie-Centrum-Charité
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergie-Centrum-Charité Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
12. IPD Sharing Statement
Links:
URL
http://www.urtikaria.net
Description
Related Info
Learn more about this trial
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
We'll reach out to this number within 24 hrs