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NCT00373776 Clinical Trial

Miltefosine for Mucosal Leishmaniasis

Leishmaniasis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00373776
Other study ID # 04--01
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 7, 2006
Last updated September 7, 2006
Start date April 2004
Est. completion date May 2006

Study information
Verified date September 2006
Source AB Foundation
Contact n/a
Is FDA regulated No
Health authority Bolivia: Ethics Committee
Study type Interventional

Clinical Trial Summary

This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Description:

Treat bolivian mucosal leishmaniasis with miltefosine.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date May 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility Inclusion Criteria:

- Mucosal leishmaniasis

Exclusion Criteria:

- Abnormal liver function tests (LFT)

- Abnormal kidney function test

- Concomitant diseases

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 28 days

Locations
Country Name City State
n/a

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 toxicity
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