Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria
Status:
Terminated
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
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 insufficient treatment response after a minimum of 1 week therapy with the maximum
labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at baseline
8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to one of the
following treatment groups as add-on to the ongoing therapy with a non-sedating antihistamine
for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and safety
evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of treatment) and
at day 56 (28 days after end of treatment).