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Miltefosine for Mucosal Leishmaniasis

This study has been completed.
Information provided by:
AB Foundation Identifier:
First received: September 7, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
This trial will study miltefosine as a treatment for mucosal leishmaniasis.

Condition Intervention Phase
Leishmaniasis Drug: miltefosine 2.5 mg/kg/day for 28 days Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by AB Foundation:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • toxicity

Estimated Enrollment: 75
Study Start Date: April 2004
Estimated Study Completion Date: May 2006
Detailed Description:
Treat bolivian mucosal leishmaniasis with miltefosine.

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • Abnormal liver function tests (LFT)
  • Abnormal kidney function test
  • Concomitant diseases
  Contacts and Locations
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Please refer to this study by its identifier: NCT00373776

Palos Blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Principal Investigator: Jaime soto, MD CIBIC
  More Information Identifier: NCT00373776     History of Changes
Other Study ID Numbers: 04--01
Study First Received: September 7, 2006
Last Updated: September 7, 2006

Keywords provided by AB Foundation:

Additional relevant MeSH terms:
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents processed this record on September 19, 2017