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

NCT00600847 | Completed Phase 4 DMC

• 2 other identifiers: P04685EudraCT-Number: 2005-006133-32
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Cold Urticaria

Keywords

urticaria; cold urticaria; acquired cold urticaria

Outcome Measures

Primary Outcomes (1)

• Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography.

  90 minutes

Secondary Outcomes (1)

• Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.

  15 minutes

Study Arms (3)

1

ACTIVE COMPARATOR

desloratadine 20 mg

Drug: desloratadine

2

ACTIVE COMPARATOR

desloratadine 5 mg

Drug: desloratadine

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

desloratadine DRUG

single dose for 7 days, oral, 20mg

1

placebo DRUG

single dose for 7 days, oral

3

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Allergie-Centrum-Charité Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Urticaria; Cold Urticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marcus Maurer, MD

  Allergie-Centrum-Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2008
• First Posted: January 25, 2008
• Study Start: November 1, 2006
• Primary Completion: November 1, 2007
• Last Updated: January 25, 2008

Record last verified: 2008-01

Locations

DE (1)