A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
Information source: Charite University, Berlin, Germany
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acquired Cold Urticaria
Intervention: desloratadine (Drug); desloratadine (Drug); placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Charite University, Berlin, Germany Official(s) and/or principal investigator(s):
Marcus Maurer, MD, Principal Investigator, Affiliation: Allergie-Centrum-Charité
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study
Primary outcome: 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: Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and
itch.
2. History of beneficial effects of antihistaminic treatment.
3. Age between 18 and 75 years.
4. 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.
5. Voluntarily signed written informed consent.
Exclusion Criteria:
1. The presence of permanent severe diseases, especially those affecting the immune
system, except ACU
2. The presence of permanent gastrointestinal condition which may influence the oral
therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations
of 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. History of adverse reactions to DL, loratadine, or other ingredients of the IMP
8. Presence of active cancer which requires chemotherapy or radiation therapy
9. Presence of acute urticaria, angioedema, or larynx edema
10. History or presence of alcohol abuse or drug addiction
11. Participation in any clinical trial within 4 weeks prior to enrolment
12. Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
13. Intake of antihistamines or leukotriene antagonists within 7 days prior to the
beginning of the study
14. Intake of oral corticosteroids 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
Locations and Contacts
Allergie-Centrum-Charité Berlin, Berlin 10117, Germany
Additional Information
Starting date: November 2006
Last updated: January 15, 2008
|
