Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
NCT ID: NCT00598611
Last Updated: 2012-05-31
Study Results
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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COMPLETED
PHASE3
29 participants
INTERVENTIONAL
2007-09-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
desloratadine 20 mg
desloratadine
singel dose, oral, 20 mg
2
desloratadine 20 mg
desloratadine
single dose, oral, 5 mg
Interventions
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desloratadine
singel dose, oral, 20 mg
desloratadine
single dose, oral, 5 mg
Eligibility Criteria
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Inclusion Criteria
2. Patients must exhibit spontaneous urticaria lesions in the randomization visit.
3. History of beneficial effects of antihistaminic treatment.
4. Age between 18 and 60 years.
5. Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
6. Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
7. Voluntarily signed written informed consent.
Exclusion Criteria
2. The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the 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. The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
8. History of adverse reactions including hypersensitivity to DL and Loratadine.
9. Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
10. Presence of active cancer which requires chemotherapy or radiation therapy.
11. Presence of acute urticaria / angioedema including laryngeal edema
12. History or presence of alcohol abuse or drug addiction.
13. Participation in any clinical trial within 4 weeks prior to enrolment.
14. Intake of oral corticosteroids or other immunosuppressive therapy 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.
17. Existing or planned placement in an institution after ruling according to ยง 40 passage 1 number 4 AMG (Arzneimittelgesetz).
18 Years
75 Years
ALL
No
Sponsors
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Essex Pharma GmbH
INDUSTRY
Charite University, Berlin, Germany
OTHER
Responsible Party
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K. Weller
Dr. Karsten Weller
Principal Investigators
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Marcus Maurer, MD
Role: PRINCIPAL_INVESTIGATOR
Allergie-Centrum-Charite
Locations
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Allergie-Centrum-Charite
Berlin, State of Berlin, Germany
Countries
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References
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Weller K, Ardelean E, Scholz E, Martus P, Zuberbier T, Maurer M. Can on-demand non-sedating antihistamines improve urticaria symptoms? A double-blind, randomized, single-dose study. Acta Derm Venereol. 2013 Mar 27;93(2):168-74. doi: 10.2340/00015555-1434.
Related Links
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Related Info
Other Identifiers
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EudraCT number: 2006-003686-13
Identifier Type: -
Identifier Source: secondary_id
P04805-V2.0
Identifier Type: -
Identifier Source: org_study_id