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Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

NCT00600548 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2010-04-15

No results posted yet for this study

Summary

The hypothesis of this trial is that the therapeutic activity and safety of oral miltefosine in Brazilian patients with cutaneous leishmaniasis is similar or superior to the intravenous standard treatment (meglumine antimoniate - Glucantime®).

Conditions

  • Treatment of Cutaneous Leishmaniasis in Brazil.

Interventions

DRUG

Miltefosine.

Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.

DRUG

Meglumine antimoniate.

Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.

DRUG

Miltefosine.

Miltefosine: Capsules containing 10 mg or 50 mg miltefosine; administered orally for 28 days at dosage of 2.5 mg/kg body weight per day.

DRUG

Meglumine antimoniate.

Meglumine antimoniate administered by intravenous route for 20 days at the dosage of 20mg/kg/day.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Ministerio de Ciencia e Innovación, Spain

    collaborator OTHER_GOV

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • AEterna Zentaris

    collaborator INDUSTRY

  • Hospital Universitário Professor Edgard Santos

    lead OTHER

Principal Investigators

  • Paulo RL Machado, MD, PhD · Federal University of Bahia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-03-31
Completion
2009-07-31

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 NCT00600548 on ClinicalTrials.gov