Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria (AECUDATT)
This study has been completed.
Sponsor:
Marcus Maurer
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Marcus Maurer, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01444196
First received: September 29, 2011
Last updated: September 30, 2011
Last verified: September 2011
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Purpose
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.
| Condition | Intervention | Phase |
|---|---|---|
|
Urticaria |
Drug: Desloratadine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU) |
Resource links provided by NLM:
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI) [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 30 |
| Study Start Date: | August 2009 |
| Study Completion Date: | May 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Desloratadine dose
|
Drug: Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Name: No arm names.
|
Dose of Desloratadine
|
Drug: Desloratadine
Every day,per mouth,in the evening, for 14 +- 2 days.
Other Name: No arm names.
|
Detailed Description:
A total of 30 patients (male and female) with ACU will be included in this study
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Informed consent signed and dated
- Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Age between 18 and 75 years
Exclusion Criteria:
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
- The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- 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
- Presence of active cancer which requires chemotherapy or radiation therapy
- Presence of alcohol abuse or drug addiction
- Intake of oral corticosteroids within 14 days prior to screening visit
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
- Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
- Pregnancy or breast-feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444196
Locations
| Germany | |
| Department of Dermatology, Venerology and Allergology | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Marcus Maurer
Johannes Gutenberg University Mainz
Investigators
| Principal Investigator: | Marcus Maurer, Prof. | Charite, University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Marcus Maurer, Head of Research Dept. of Dermatology, Charite University, Berlin, Germany |
| ClinicalTrials.gov Identifier: | NCT01444196 History of Changes |
| Other Study ID Numbers: | 2008-005746-22, 2008-005746-22 |
| Study First Received: | September 29, 2011 |
| Last Updated: | September 30, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
ACU acquired cold urticaria |
Additional relevant MeSH terms:
|
Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Desloratadine Loratadine Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Antipruritics Dermatologic Agents Therapeutic Uses Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013