Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

June 8, 2015 updated by: Juliana Silva, Brasilia University Hospital

Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • DF
      • Brasilia, DF, Brazil, 70910-900
        • Brasilia University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Standard Treatment
Meglumine antimoniate as recommended by the Brazilian Ministry of Health
Drug: Standard Treatment Meglumine antimoniate
20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
Other Names:
  • pentavalent antimonial
EXPERIMENTAL: Tested Intervention
Miltefosine as the tested intervention
Drug: Miltefosine
1 Capsule of 50mg, taken orally 2 times a day for 28 days
Other Names:
  • Impavido

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure
Time Frame: 6 months
Re-epithelizations of mucosal ulcers or regression of symptoms
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse effects
Time Frame: 6 months
laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brasilia University Hospital

Investigators

  • Principal Investigator: Juliana SF Silva, MD, University of Brasilia
  • Study Chair: Raimunda NR Sampaio, PhD, University of Brasilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (ESTIMATE)

June 22, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 8, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MILTHUB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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