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Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

NCT01377974 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2015-06-09

No results posted yet for this study

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.

Conditions

  • Leishmaniasis
  • Leishmaniasis, Mucocutaneous

Interventions

DRUG

Miltefosine

1 Capsule of 50mg, taken orally 2 times a day for 28 days

DRUG

Standard Treatment Meglumine antimoniate

20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health

Sponsors & Collaborators

  • Brasilia University Hospital

    lead OTHER

Principal Investigators

  • Juliana SF Silva, MD · University of Brasilia

  • Raimunda NR Sampaio, PhD · University of Brasilia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2013-06-30
Completion
2014-12-31

Countries

  • Brazil

Study Locations

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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 NCT01377974 on ClinicalTrials.gov