Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis
Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 20, 2011
CompletedFirst Posted
Study publicly available on registry
June 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 9, 2015
June 1, 2015
3.9 years
June 20, 2011
June 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cure
Re-epithelizations of mucosal ulcers or regression of symptoms
6 months
Secondary Outcomes (1)
Adverse effects
6 months
Study Arms (2)
Standard Treatment
ACTIVE COMPARATORMeglumine antimoniate as recommended by the Brazilian Ministry of Health
Tested Intervention
EXPERIMENTALMiltefosine as the tested intervention
Interventions
1 Capsule of 50mg, taken orally 2 times a day for 28 days
20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brasilia University Hospital
Brasília, Federal District, 70910-900, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Juliana SF Silva, MD
University of Brasilia
- STUDY CHAIR
Raimunda NR Sampaio, PhD
University of Brasilia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Juliana Silva
Study Record Dates
First Submitted
June 20, 2011
First Posted
June 22, 2011
Study Start
July 1, 2009
Primary Completion
June 1, 2013
Study Completion
December 1, 2014
Last Updated
June 9, 2015
Record last verified: 2015-06