Status:
TERMINATED
Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
Lead Sponsor:
Marcus Maurer
Collaborating Sponsors:
Charite University, Berlin, Germany
Conditions:
Chronic Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is defined by insu...
Eligibility Criteria
Inclusion
- Inclusion criteria Informed consent signed and dated Outpatients with moderate to severe spontaneous CU defined by UAS of ≥15 (under the maximum labelled dose of a non-sedating antihistamine Resistant to standard treatment with antihistamines after a minimum of 7 days therapy with the maximum labelled dose of a non-sedating antihistamine (levocetirizine, cetirizine, fexofenadine, desloratadine, loratadine, ebastine, mizolastine Aged more than 18 years Reliable method of contraception for both women of childbearing potential as well as men 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.
- Exclusion Criteria:
- Pregnancy or lactation Participation in another clinical trial within the last 30 days Body weight ≤ 45 kg 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).
- Skin symptoms caused primarily by physical urticaria Urticaria vasculitis Known hypersensitivity to miltefosine Retinal pathology Leishmaniasis Gastrointestinal disturbances which may influence oral resorption (e.g. chronic diarrhoea diseases, congenital malformations or major surgical resection of gastrointestinal tract).
- History within 5 years or presence of myocardial infarction or any other major cardiac disorder.
- Serum-creatinine and/or BUN 1.5 times above the upper reference value GOT and/or GPT and/or alkaline phosphatase 3 times above the upper reference value).
- Sjögren-Larsson-Syndrome. Malignancy within the last 5 years requiring chemotherapy or radiation therapy. Mental disorders that interfere with the evaluation of study end-points Drug or alcohol dependency Any other chronic or acute illness requiring systemic treatment which might have any influence on the outcome of the study in the 4 weeks before start of treatment and during the study (investigator's decision).
- Immunodeficiency including HIV During the past 10 days before start of treatment and during the study Topical steroids H2 antihistamines Leukotriene antagonists H1 antihistamine other then basic therapy During the past 2 weeks before start of treatment and during the study Ketotifen Doxepin During the past 4 weeks before start of treatment and during the study Systemic corticosteroids UV therapy including PUVA Systemic immunosuppressives including corticosteroids, immunomodulators, immunostimulants During the past 12 weeks before start of treatment and during the study Astemizole Tranquilizers, antidepressants, sedatives, hypnotics, antiepileptics and other CNS active agents, except treatment with tricyclics that is stable for at least 12 weeks prior to screening and throughout the trial
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT01170949
Start Date
September 1 2008
End Date
April 1 2010
Last Update
December 26 2016
Active Locations (1)
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1
Charité University
Berlin, Germany, 10179