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

Genetic and Rare Diseases Information Center resources: 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

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, see Learn About Clinical Studies.

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 Euglenozoa Infections Parasitic Diseases Protozoan Infections Skin Diseases Skin Diseases, Infectious Skin Diseases, Parasitic Miltefosine	Anti-Infective Agents Antifungal Agents Antineoplastic Agents Antiparasitic Agents Antiprotozoal Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 25, 2015

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