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Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Brasilia University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Brasilia University Hospital
ClinicalTrials.gov Identifier:
NCT01377974
First received: June 20, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

The purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.


Condition Intervention Phase
Leishmaniasis
Leishmaniasis, Mucocutaneous
Drug: Miltefosine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Miltefosine to Treat Mucosal Leishmaniasis at Federal District, Brazil

Resource links provided by NLM:


Further study details as provided by Brasilia University Hospital:

Primary Outcome Measures:
  • Cure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Re-epithelizations of mucosal ulcers or regression of symptoms


Secondary Outcome Measures:
  • Adverse effects [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    laboratory tests of blood, kidney, liver and cardiac functions, partients will be asked about nausea, vomiting, diarrhea, myalgia, or other symptoms


Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Miltefosine
    1 Capsule of 50mg, taken orally 2 times a day for 28 days
    Other Name: Impavido
Detailed Description:

Mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the New World. It causes deformities and may be lethal if not treated. It is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. Also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. The standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. On the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. Few clinical trials have being performed in Central and South American countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin B. None studies comparing its efficacy to the standard treatment have being done.

  Eligibility

Ages Eligible for Study:   12 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of mucosal leishmaniasis
  • Not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study
  • Use of contraceptive method, if female on child bearing age
  • Sign the agreement and consent form

Exclusion Criteria:

  • Previous leishmanicidal treatment on the past 6 months before the enrollment on the study
  • Electrocardiogram abnormalities on the pretreatment exams
  • Previous kidney, liver and/or heart diseases
  • Diabetes Mellitus
  • Hypersensitivity to miltefosine or meglumine antimoniate
  • Pregnant women or breastfeeding mothers
  • Hiv patients
  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: NCT01377974

Contacts
Contact: Raimunda NR Sampaio, PhD +556134485415 raimunda.sampaio@gmail.com
Contact: Juliana SF Silva, MD +556181338370 jusaboia@hotmail.com

Locations
Brazil
Brasilia University Hospital Recruiting
Brasilia, DF, Brazil, 70910-900
Contact: Raimunda NR Sampaio, PhD    +556134485415    raimunda.sampaio@gmail.com   
Principal Investigator: Juliana SF Silva, MD         
Sponsors and Collaborators
Brasilia University Hospital
Investigators
Principal Investigator: Juliana SF Silva, MD University of Brasilia
Study Chair: Raimunda NR Sampaio, PhD University of Brasilia
  More Information

No publications provided

Responsible Party: JULIANA SILVA, UNIVERSITY OF BRASILIA
ClinicalTrials.gov Identifier: NCT01377974     History of Changes
Other Study ID Numbers: MILTHUB
Study First Received: June 20, 2011
Last Updated: June 20, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Brasilia University Hospital:
Leishmaniasis
Mucocutaneous Leishmaniasis
Therapeutics
meglumine antimoniate
miltefosine

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

ClinicalTrials.gov processed this record on August 20, 2014