Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
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|ClinicalTrials.gov Identifier: NCT00386750|
Recruitment Status : Terminated
First Posted : October 12, 2006
Last Update Posted : April 27, 2012
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
|Condition or disease||Intervention/treatment||Phase|
|Malaria Falciparum||Drug: Artemether-lumefantrine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||265 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||November 2005|
|Actual Study Completion Date :||November 2005|
- Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
- Rate of auditory changes following 3 days of treatment with artemether-lumefantrine at Days 7, 28, and 42 days assessed by pure tone thresholds assessments (a type of hearing test)
- Changes in auditory function with a non-ACT (artemisinin combined therapy) antimalarial (Malarone, atovaquone-proguanil) and another ACT combination (artesunate-mefloquine) assessed by pure tone thresholds (a type of hearing test)
- Relationship between changes in auditory function and drug exposure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00386750
|Study Chair:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|