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Efficacy and Safety of Miltefosine in Antihistamine Resistant Chronic Urticaria

NCT01170949 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2016-12-26

Study results available
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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

DRUG

Miltefosine

50 or 100 or 150mg per day

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • Marcus Maurer

    lead OTHER

Principal Investigators

  • Markus Magerl, MD · Charité University, Berlin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2008-09-30
Completion
2010-04-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01170949 on ClinicalTrials.gov