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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acquired Cold Urticaria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

desloratadine 20 mg

Group Type ACTIVE_COMPARATOR

desloratadine

Intervention Type DRUG

single dose for 7 days, oral, 20mg

2

desloratadine 5 mg

Group Type ACTIVE_COMPARATOR

desloratadine

Intervention Type DRUG

single dose for 7 days, oral, 5 mg

3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

single dose for 7 days, oral

Interventions

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desloratadine

single dose for 7 days, oral, 20mg

Intervention Type DRUG

desloratadine

single dose for 7 days, oral, 5 mg

Intervention Type DRUG

placebo

single dose for 7 days, oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No