![]() |
|
![]() |
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Medicines for Malaria Venture Shin Poong Pharmaceuticals |
Information provided by: | Medicines for Malaria Venture |
ClinicalTrials.gov Identifier: | NCT00422084 |
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of Coartem® (artemether lumefantrine) in children and adults with acute uncomplicated P falciparum malaria.
Condition | Intervention | Phase |
Malaria |
Drug: Pyronaridine artesunate Drug: Coartem® (artemether lumefantrine) |
Phase III |
MedlinePlus related topics: | Malaria |
Drug Information available for: | Artesunate Artemether Benflumetol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Comparative, (Double-Blind, Double-Dummy), Randomised, Multi-Centre, Clinical Study to Assess the Safety and Efficacy of Fixed Dose Formulation of Oral Pyronaridine Artesunate Tablet (180:60 mg) Versus Coartem® (Artemether Lumefantrine) in Children and Adult Patients With Acute Uncomplicated Plasmodium Falciparum Malaria |
Estimated Enrollment: | 1269 |
Study Start Date: | January 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Pyronaridine artesunate
|
Drug: Pyronaridine artesunate
once a day for 3 days
|
2: Active Comparator
Arthemether lumefantrine
|
Drug: Coartem® (artemether lumefantrine)
twice a day for 3 days
|
Artemisinin-based combination therapies (ACTs) are considered today by WHO to be the best anti-malarials in terms of efficacy and lower propensity to resistance. Pyronaridine artesunate is a new ACT in development to treat acute uncomplicated malaria. Pyronaridine and artesunate are antimalarial agents with a history of clinical use both separately and in combination with other drugs. Each drug has powerful anti-schizonticidal actions. The aim of a fixed dose combination of pyronaridine and artesunate in the treatment of uncomplicated acute malaria is to provide rapid reduction in parasitemia with a once-daily three-day regimen, thereby improving compliance and reducing the risk of recrudescence through the slower elimination of pyronaridine.
Ages Eligible for Study: | 3 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of acute uncomplicated P. falciparum mono-infection confirmed by:
Exclusion Criteria:
Congo, DRC | |||||
Ecole de Santé Publique, Faculté de Médecine, Université de Kinshasa | |||||
Kinshasa, DRC, Congo | |||||
Gambia | |||||
Farafenni Field Station, c/o: MRC Laboratories | |||||
Fajara, Gambia | |||||
Ghana | |||||
Komfo Anoykye Teaching Hospital | |||||
Kumasi, Ghana | |||||
Indonesia, Nusa Tenggara Timur | |||||
RSUD TC Hillers | |||||
Maumere, Nusa Tenggara Timur, Indonesia, 86113 | |||||
Indonesia, Papua | |||||
Jayapura General Hospital (RSUD) DOK II | |||||
Jayapura, Papua, Indonesia | |||||
Kenya | |||||
Siaya District Hospital, Medical Superintendent's office | |||||
Siaya Town, Kenya | |||||
Mali | |||||
Malaria Research and Training Center, Faculté de Médecine, de Pharmacie et d'Ondonto-stomatologie | |||||
Bamako, Mali | |||||
Mozambique | |||||
Instituto Nacional de Saude, Ministero de Saude | |||||
Maputo, Mozambique | |||||
Philippines | |||||
Puerto Princesa General Hospital | |||||
Puerto Princesa, Philippines | |||||
Senegal, Dakar Fann | |||||
Service de Parasitologie, Faculté de Médecine, Université Cheikh Anta Diop | |||||
Dakar, Dakar Fann, Senegal |
Medicines for Malaria Venture |
Shin Poong Pharmaceuticals |
Study Director: | Claude Oeuvray, PhD | Medicines for Malaria Venture |
Medicines for Malaria Venture 
![]()   |
Shin Poong Pharmaceuticals 
![]()   |
Responsible Party: | Medicines for Malaria Venture ( Isabelle Borghini Fuhrer ) |
Study ID Numbers: | SP-C-005-06 |
First Received: | January 12, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00422084 |
Health Authority: | Gambia: MRC Ethics Committee; Senegal: Ministere de la sante; Mali: Ministry of Health; Mozambique: Ministry of Health (MISAU); Ghana: Ministry of Health; Philippines: Bureau of Food and Drugs; Kenya: Institutional Review Board; Indonesia: Food and Drug Control Agency (BPOM); République Démocratique du Congo: Ethics Committee Review |
|
|
|
|
|
![]() |