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An Open-label, Single-center Study of the Effects of Co-artemether, Atovaquone-proguanil, and Artesunate-mefloquine on Auditory Function Following the Treatment of Acute Uncomplicated Plasmodium Falciparum Malaria in Patients 12 Years of Age or Older.
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA. To evaluate the effects of artemether/ lumefantrine on the auditory function.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | TERMINATED |
| Enrolment | 265 |
| Start date | 2005-06 |
| Completion | 2005-11 |
Conditions
- Malaria
- Falciparum
Interventions
- Artemether-lumefantrine
Primary outcomes
- Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).