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Miltefosine for Mucosal Leishmaniasis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00373776
First Posted: September 8, 2006
Last Update Posted: September 8, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AB Foundation
  Purpose
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Mucosal leishmaniasis

Exclusion Criteria:

  • Abnormal liver function tests (LFT)
  • Abnormal kidney function test
  • Concomitant diseases
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00373776


Locations
Bolivia
Palos Blancos, Bolivia
Sponsors and Collaborators
AB Foundation
Investigators
Principal Investigator: Jaime soto, MD CIBIC
  More Information

ClinicalTrials.gov Identifier: NCT00373776     History of Changes
Other Study ID Numbers: 04--01
First Submitted: September 7, 2006
First Posted: September 8, 2006
Last Update Posted: September 8, 2006
Last Verified: September 2006

Keywords provided by AB Foundation:
mucosal
leishmaniasis
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Miltefosine
Antifungal Agents
Anti-Infective Agents
Antineoplastic Agents
Antiprotozoal Agents
Antiparasitic Agents