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Miltefosine for Mucosal Leishmaniasis

This study has been completed.
Sponsor:
Information provided by:
AB Foundation
ClinicalTrials.gov Identifier:
NCT00373776
First received: September 7, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Leishmaniasis
U.S. FDA Resources

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373776

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

No publications provided

ClinicalTrials.gov Identifier: NCT00373776     History of Changes
Other Study ID Numbers: 04--01
Study First Received: September 7, 2006
Last Updated: September 7, 2006
Health Authority: Bolivia: Ethics Committee

Keywords provided by AB Foundation:
mucosal
leishmaniasis
miltefosine

Additional relevant MeSH terms:
Leishmaniasis
Leishmaniasis, Mucocutaneous
Euglenozoa Infections
Protozoan Infections
Parasitic Diseases
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases
Leishmaniasis, Cutaneous
 Miltefosine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents

ClinicalTrials.gov processed this record on May 22, 2013