Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
NCT ID: NCT00444106
Last Updated: 2011-04-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
265 participants
INTERVENTIONAL
2007-05-31
2008-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Artemether-lumefantrine (Coartem)
Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days, dosage dependent on body weight.
Artemether-lumefantrine
Atovaquone-proguanil (Malarone)
Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days, dosage dependent on body weight.
Atovaquone-proguanil
Artesunate-mefloquine
Artesunate-mefloquine tablets containing 50 mg artesunate (Plasmotrim) and 250 mg mefloquine (Mephaquin). Artesunate 4 mg/kg/day (for 3 days) and mefloquine 25 mg/kg/day (days 2 and 3) total dose was given once daily dependent upon body weight.
Artesunate-mefloquine
Interventions
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Artesunate-mefloquine
Atovaquone-proguanil
Artemether-lumefantrine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Accepts Healthy Volunteers
* P. falciparum parasitemia between 1,000 and 100,000 parasites/μl
* History of fever or presence of fever (temperature ≥ 37.5°C)
Exclusion Criteria
* Ingestion of various antimalarial drugs, or antibiotics in the previous 2 weeks to 2 months
* History of any drug-related hearing impairment
* Abnormal hearing function at study entry
* Exposure to sustained loud noises, by self-report, within the past 24 hours
* Present ear problems
* Pregnant or lactating (urine test for β-HCG) to be performed on any woman of child bearing age)
12 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis
Principal Investigators
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Novartis
Role: STUDY_DIRECTOR
Novartis
Locations
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Novartis Investigational Site
Tumaco, , Colombia
Countries
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Other Identifiers
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CCOA566A2417
Identifier Type: -
Identifier Source: org_study_id
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