A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions (AUDACU)

Charité University Medicine Berlin

Status and phase: Completed; Phase 4

Conditions: Acquired Cold Urticaria

Treatments: Drug: desloratadine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00600847

EudraCT-Number: 2005-006133-32

P04685

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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33 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

desloratadine 20 mg

Treatment:

Drug: desloratadine

Drug: desloratadine

2

Active Comparator group

Description:

desloratadine 5 mg

Treatment:

Drug: desloratadine

Drug: desloratadine

3

Placebo Comparator group

Treatment:

Drug: placebo