Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484900
Status:
COMPLETED
Last Update Posted:
2008-03-26
First Post:
2007-06-08
Brief Title:
Multi-Centre Trial Comparing Three Artemisinin-Based Combination Treatments on P Falciparum Malaria
Sponsor:
Dafra Pharma
Organization:
Dafra Pharma
Study Overview
Official Title:
Open Randomized Multi-Centre Trial Comparing Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 3 Days Artesunate-Sulfamethoxypyrazine-Pyrimethamine FDC Over 48 Hours and Artemether-Lumefantrine FDC Over 3 Days on P Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2007-06
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:
The purpose of this open randomised multi-centre clinical trial is to test the hypothesis that three pills of the fixed dose combination artesunatesulfamethoxypyrazinepyrimethamine administered over 24 hours is not inferior in efficacy to the same drug administered over 48 hours and that the fixed dose combination artesunatesulfamethoxypyrazinepyrimethamine AsSMP fdc independently of the duration of its dose interval is not inferior in efficacy to 6 - 24 pills number of pills administered to respectively children and adultsof the 60 hours treatment of artemetherlumefantrine for the treatment of uncomplicated P falciparum malaria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None