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Sponsors and Collaborators: |
Medicines for Malaria Venture Shin Poong Pharmaceuticals |
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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 |
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Malaria |
Drug: Pyronaridine artesunate Drug: Coartem® (artemether lumefantrine) |
Phase III |
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 |
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1: Experimental
Pyronaridine artesunate
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Drug: Pyronaridine artesunate
once a day for 3 days
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2: Active Comparator
Arthemether lumefantrine
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Drug: Coartem® (artemether lumefantrine)
twice a day for 3 days
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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 |
Study Director: | Claude Oeuvray, PhD | Medicines for Malaria Venture |
Responsible Party: | Medicines for Malaria Venture ( Isabelle Borghini Fuhrer ) |
Study ID Numbers: | SP-C-005-06 |
Study 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 |
Malaria ACT P falciparum |
Benflumetol Artesunate Artemether-lumefantrine combination Protozoan Infections Clotrimazole Pyronaridine |
Miconazole Tioconazole Parasitic Diseases Malaria Artemether Malaria, Falciparum |
Anti-Infective Agents Antiprotozoal Agents Coccidiosis Antiplatyhelmintic Agents Anthelmintics Schistosomicides Pharmacologic Actions |
Antimalarials Antiparasitic Agents Therapeutic Uses Antifungal Agents Amebicides Coccidiostats |