CompletedPhase 2

Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

Brazil40 participantsStarted 2009-07

Plain-language summary

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

Who can participate

Age range12 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Clinical diagnosis of mucosal leishmaniasis * Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study * Use of contraceptive method, if female on child bearing age * Sign the agreement and consent form Exclusion Criteria: * Previous leishmanicidal treatment on the past 6 months before the enrollment on the study * Electrocardiogram abnormalities on the pretreatment exams * Previous kidney, liver and/or heart diseases * Diabetes Mellitus * Hypersensitivity to miltefosine or meglumine antimoniate * Pregnant women or breastfeeding mothers * Hiv patients

What they're measuring

Cure

Timeframe: 6 months

Trial details

NCT IDNCT01377974

SponsorBrasilia University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

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