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Main
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Note: This record shows only 22 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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 January 2024 |
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Main ID: |
NCT02530697 |
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Date of registration:
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19/08/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: A Clinical Trial in Brazil
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Scientific title:
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The Association of Miltefosine and Pentoxifylline to Treat Mucosal and Cutaneous Leishmaniasis: An Open-label, Randomized Clinical Trial in Brazil |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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160 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02530697 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mucosal and/or cutaneous leishmaniasis, not treated or at least 6 months without any
treatment to leishmaniasis;
- For patients with cutaneous lesions: duration of disease longer then a 1 month and
shorter then 4 yeas; 1 to 3 lesions; larger lesions from 10mm to 50mm;
- Ages between 18 and 80 years old;
- Fertile female patients should use at least two contraceptive methods (hormonal and
barrier);
- Agree to participate in the study and sign the informed consent term.
Exclusion Criteria:
- Use of any leishmanicidal drugs six months prior;
- Clinical or laboratorial evidences of electrocardiographic disorders;
- Renal, hepatic, cardiac diseases, uncontrolled diabetes or AIDS;
- Hypersensitivity to meglucamine antimoniate;
- Pregnancy or lactation;
- Fertile females that do not agree to use contraceptive methods;
- Patients that do not agree to the informed consent term.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leishmaniasis
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Intervention(s)
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Drug: Meglumine antimoniate
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Drug: Pentoxifylline
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Drug: Miltefosine
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Primary Outcome(s)
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Failure
[Time Frame: 90 days]
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Relapse
[Time Frame: 90 days]
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Cure
[Time Frame: 90 days]
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Secondary ID(s)
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40068714.1.0000.5558
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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