Clinical trial NCT00600847: A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acquired Cold Urticaria
Keywords: urticaria
cold urticaria
acquired cold urticaria
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography.
timeFrame: 90 minutes
Secondary outcomes:
measure: Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Allergie-Centrum-Charité Berlin
Study officials:
affiliation: Allergie-Centrum-Charité
name: Marcus Maurer, MD
role: PRINCIPAL_INVESTIGATOR
References: