Status:
COMPLETED
Evaluation of Potential Effect of Artemether - Lumefantrine and Malaria Drugs on Auditory Function
Lead Sponsor:
Novartis
Conditions:
Malaria
Falciparum
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
To evaluate the potential effects of artemether- lumefantrine on the auditory function
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 12 years of age or older
- 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
- Signs/symptoms of severe/complicated malaria
- 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)
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT00444106
Start Date
May 1 2007
End Date
November 1 2008
Last Update
April 5 2011
Active Locations (1)
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1
Novartis Investigational Site
Tumaco, Colombia