| 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 |
| |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Efficacy Study |
| Acquired Cold Urticaria |
- Drug: desloratadine
- Drug: placebo
|
- Active Comparator: desloratadine 20 mg
- Active Comparator: desloratadine 5 mg
|
| |
| |
| Completed |
| 33 |
|
| November 2007 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
- Pregnancy or breast-feeding
|
| Both |
| 18 Years to 75 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Germany |
| |
| NCT00600847 |
| Marcus Maurer, MD, Allergie-Centrum-Charité |
| P04685, EudraCT-Number: 2005-006133-32 |
| Charite University, Berlin, Germany |
|
| Principal Investigator: |
Marcus Maurer, MD |
Allergie-Centrum-Charité |
|
|
| Charite University, Berlin, Germany |
| January 2008 |
