Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422084
Status:
COMPLETED
Last Update Posted:
2021-11-02
First Post:
2007-01-12
Brief Title:
Pyronaridine Artesunate 31 Versus Coartem in P Falciparum Malaria Patients
Sponsor:
Medicines for Malaria Venture
Organization:
Medicines for Malaria Venture
Study Overview
Official Title:
A Phase III Comparative Double-blind Double-dummy Randomised Multi-centre Study to Assess the Efficacy of Pyronaridine Artesunate 18060mg Versus Coartem Artemether Lumefantrine in Children Adult Patients With Falciparum Malaria
Status:
COMPLETED
Status Verified Date:
2021-10
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 primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate Pyramax PA with that of Coartem artemether lumefantrine AL in children and adults with uncomplicated P falciparum malaria in Africa and South East Asia
Detailed Description:
This is a multi-centre comparative randomised double-blind double-dummy parallel-group non-inferiority study comparing the efficacy and safety of the fixed combination of PA with that of AL in the treatment of acute uncomplicated P falciparum malaria The study population will include 1269 patients comprising male and female children 20 kg body weight and adults recruited from study sites in Africa and South East Asia
Patients will be randomised to receive either oral PA 18060mg tablets once a day plus AL-placebo twice a day for 3 consecutive days Days 0 1 and 2 or AL twice a day plus PA-placebo once a day for 3 consecutive days Days 0 1 and 2 in a 21 ratio The dose range of PA covered by this regimen is 7224 mgkg to 13846 mgkg respectively which has been shown to be effective and safe in Phase I and II studies Posology will be based on body weight ranges for both the PA and AL regimens
Patients will be confined to the study facility for 4 days Days 0 1 2 and 3 and remain near the study site for 7 days or once fever and parasite clearance has been confirmed for 24 hours - whichever occurs later
The primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response ACPR on Day 28 Scheduled follow-up visits will continue until completion of the study at Day 42 In the case of adverse events reported and unresolved at Day 42 patients will be followed up for a further 30 days or until resolution of the event
Patients will be randomised to receive either oral PA 18060mg tablets once a day plus AL-placebo twice a day for 3 consecutive days Days 0 1 and 2 or AL twice a day plus PA-placebo once a day for 3 consecutive days Days 0 1 and 2 in a 21 ratio The dose range of PA covered by this regimen is 7224 mgkg to 13846 mgkg respectively which has been shown to be effective and safe in Phase I and II studies Posology will be based on body weight ranges for both the PA and AL regimens
Patients will be confined to the study facility for 4 days Days 0 1 2 and 3 and remain near the study site for 7 days or once fever and parasite clearance has been confirmed for 24 hours - whichever occurs later
The primary efficacy end point for the study is the proportion of patients with PCR-corrected adequate clinical and parasitological response ACPR on Day 28 Scheduled follow-up visits will continue until completion of the study at Day 42 In the case of adverse events reported and unresolved at Day 42 patients will be followed up for a further 30 days or until resolution of the event
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