Trial of Miltefosine in Cutaneous Leishmaniasis (Brazil)

PHASE2CompletedINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

March 31, 2009

Study Completion Date

July 31, 2009

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.

Trial Locations (2)

Unknown

Fundação de Medicina Tropical do Amazonas, Manaus

Posto de Saúde de Corte de Pedra, Tancredo Neto

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

collaborator

Ministerio de Ciencia e Innovación, Spain

OTHER_GOV

collaborator

Ministry of Health, Brazil

OTHER_GOV

collaborator

AEterna Zentaris

INDUSTRY

lead

Hospital Universitário Professor Edgard Santos

OTHER