NCT01170949

Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

Randomised, Double-blind, Placebo-controlled Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Marcus Maurer · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Urticaria

Interventions

Type	Name	Description
DRUG	Miltefosine	50 or 100 or 150mg per day
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-09-01
• Primary completion: 2008-09-01
• Completion: 2010-04-01
• First posted: 2010-07-28
• Last updated: 2016-12-26
• Results posted: 2016-12-26

Locations

1 site across 1 country: Germany