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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00600847
First received: January 15, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 15, 2008
January 15, 2008
November 2006
November 2007   (final data collection date for primary outcome 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. [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Acquired Cold Urticaria
  • Drug: desloratadine
    single dose for 7 days, oral, 20mg
  • Drug: desloratadine
    single dose for 7 days, oral, 5 mg
  • Drug: placebo
    single dose for 7 days, oral
  • Active Comparator: 1
    desloratadine 20 mg
    Intervention: Drug: desloratadine
  • Active Comparator: 2
    desloratadine 5 mg
    Intervention: Drug: desloratadine
  • Placebo Comparator: 3
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
Not Provided
November 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00600847
P04685, EudraCT-Number: 2005-006133-32
Yes
Marcus Maurer, MD, Allergie-Centrum-Charité
Charite University, Berlin, Germany
Not Provided
Principal Investigator: Marcus Maurer, MD Allergie-Centrum-Charité
Charite University, Berlin, Germany
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP