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NCT00373568 Clinical Trial

Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis

Leishmaniasis Clinical Trial

Official title:
Miltefosine (42 Days) for Mucosal Leishmaniasisi

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00373568
Other study ID # 05--01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 7, 2006
Last updated May 29, 2010
Start date April 2005
Est. completion date December 2007

Study information
Verified date May 2010
Source AB Foundation
Contact n/a
Is FDA regulated No
Health authority Bolivia: Ethics Committee
Study type Interventional

Clinical Trial Summary

Miltefosine (longer course) will be used to try to improve the cure rate of mucosal leishmaniasis

Description:

Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug for bolivian mucosal leishmaniasisi

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 80 Years
Eligibility Inclusion Criteria:

- Mucosal leishmaniasis

Exclusion Criteria:

- No comcomitant disease as judged by laboratory and clinical parameters

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• miltefosine: 2.5 mg/kg/day for 42 days

Locations
Country Name City State
Bolivia Palos Blancos Palos Blancos

Sponsors (1)
Lead Sponsor Collaborator
AB Foundation

Country where clinical trial is conducted

Bolivia, 

Outcome
Type Measure Description Time frame Safety issue
Primary efficacy
Secondary safety
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