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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 17 October 2012
Main ID:  NCT01301937
Date of registration: 20/02/2011
Primary sponsor: Oswaldo Cruz Foundation
Public title: Low Antimonial Dosage in American Mucosal Leishmaniasis
Scientific title: Phase III Clinical Trial for Mucosal or Mucocutaneous Leishmaniasis. Comparison Between the Standard and Alternative Antimonial Schemes
Date of first enrolment: October 2008
Target sample size: 76
Recruitment status: Recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

Inclusion Criteria:

- Mucosal or mucocutaneous leishmaniasis with parasitological diagnosis by one or more
of the following methods: direct examination (imprint), histopathology, culture,
immunohistochemistry, or PCR.

Exclusion Criteria:

- Women who do not use contraceptives or do it badly

- Pregnant women

- Children under 13 years

- Previous antimonial treatment for LM

- Immunosuppressive therapy (steroids, cancer chemotherapy) or medicines for
tuberculosis or leprosy.

- Presence of altered baseline clinical adverse effect level equivalent to > G3

- Presence of altered basal laboratory adverse effect level equivalent to > G2

- Presence of baseline electrocardiographic changes equivalent to an adverse effect
level > G4 and / or baseline QTc > 0.46 ms (equivalent to AE level G1)

Age minimum: 13 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Mucocutaneous Leishmaniasis
Mucosal Leishmaniasis
Drug: Meglumine antimoniate
Primary Outcome(s)
Efficacy of meglumine antimoniate in the treatment of mucosal leishmaniasis [Time Frame: 6 years]
Secondary Outcome(s)
Safety of meglumine antimoniate in the treatment of mucosal leishmaniasis [Time Frame: 6 years]
Secondary ID(s)
low dosage ML
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
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