Back to resultsMiltefosine for Mucosal Leishmaniasis
Primary Purpose
Leishmaniasis
Status
Completed
Phase
Phase 1
Locations
Bolivia
Study Type
Interventional
Intervention
miltefosine 2.5 mg/kg/day for 28 days
Sponsored by
About this trial
This is an interventional treatment trial for Leishmaniasis focused on measuring mucosal, leishmaniasis, miltefosine
Eligibility Criteria
Inclusion Criteria:
- Mucosal leishmaniasis
Exclusion Criteria:
- Abnormal liver function tests (LFT)
- Abnormal kidney function test
- Concomitant diseases
Sites / Locations
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
toxicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00373776
Brief Title
Miltefosine for Mucosal Leishmaniasis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
AB Foundation
4. Oversight
5. Study Description
Brief Summary
This trial will study miltefosine as a treatment for mucosal leishmaniasis.
Detailed Description
Treat bolivian mucosal leishmaniasis with miltefosine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leishmaniasis
Keywords
mucosal, leishmaniasis, miltefosine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
miltefosine 2.5 mg/kg/day for 28 days
Primary Outcome Measure Information:
Title
Efficacy
Secondary Outcome Measure Information:
Title
toxicity
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mucosal leishmaniasis
Exclusion Criteria:
Abnormal liver function tests (LFT)
Abnormal kidney function test
Concomitant diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime soto, MD
Organizational Affiliation
CIBIC
Official's Role
Principal Investigator
Facility Information:
City
Palos Blancos
Country
Bolivia
12. IPD Sharing Statement
Learn more about this trial
Miltefosine for Mucosal Leishmaniasis
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