NCT00600548

Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

Clinical Trial to Assess Efficacy and Safety of Orally Administered Miltefosine in Brazilian Patients With Cutaneous Leishmaniasis Compared to the Standard Care as Active Control

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Hospital Universitário Professor Edgard Santos · Academic / Other
• Sex: All
• Age: 2 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2007-07-01
• Primary completion: 2009-03-01
• Completion: 2009-07-01
• First posted: 2008-01-25
• Last updated: 2010-04-15

Locations

2 sites across 1 country: Brazil