Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-27 @ 6:27 AM
Study NCT ID:
NCT00386750
Status:
TERMINATED
Last Update Posted:
2012-04-27
First Post:
2006-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Artemether - Lumefantrine, and Other Malaria Drugs and Their Effect on the Auditory Function
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
THIS STUDY IS NOT ENROLLING PATIENTS IN THE USA.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
To evaluate the effects of artemether/ lumefantrine on the auditory function.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: