Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
This study has been terminated.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: October 11, 2006
Last updated: April 25, 2012
Last verified: April 2012
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Auditory abnormalities at Day 7 assessed by Auditory Brainstem Response (ABR) wave form latencies (a type of hearing test).
Secondary Outcome Measures:
- 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.
|Study Start Date:||June 2005|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
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