NCT00373776

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
Last Updated

September 8, 2006

Status Verified

September 1, 2006

First QC Date

September 7, 2006

Last Update Submit

September 7, 2006

Conditions

Leishmaniasis

Keywords

mucosalleishmaniasismiltefosine

Outcome Measures

Primary Outcomes (1)

  • Efficacy

Secondary Outcomes (1)

  • toxicity

Interventions

miltefosine 2.5 mg/kg/day for 28 daysDRUG

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mucosal leishmaniasis

You may not qualify if:

  • Abnormal liver function tests (LFT)
  • Abnormal kidney function test
  • Concomitant diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Palos Blancos, Bolivia

Location

MeSH Terms

Conditions

Leishmaniasis

Interventions

miltefosine

Condition Hierarchy (Ancestors)

Euglenozoa InfectionsProtozoan InfectionsParasitic DiseasesInfectionsSkin Diseases, ParasiticVector Borne DiseasesSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jaime soto, MD

    CIBIC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

April 1, 2004

Study Completion

May 1, 2006

Last Updated

September 8, 2006

Record last verified: 2006-09

Locations

BO(1)