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Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422084
Recruitment Status : Completed
First Posted : January 15, 2007
Last Update Posted : May 20, 2008
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture

Brief Summary:
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 or disease Intervention/treatment Phase
Malaria Drug: Pyronaridine artesunate Drug: Coartem® (artemether lumefantrine) Phase 3

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : January 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: 1
Pyronaridine artesunate
Drug: Pyronaridine artesunate
once a day for 3 days
Other Name: Pyramax

Active Comparator: 2
Arthemether lumefantrine
Drug: Coartem® (artemether lumefantrine)
twice a day for 3 days
Other Name: Coartem

Primary Outcome Measures :
  1. PCR-corrected adequate clinical and parasitological response (ACPR) rate on Day 28 [ Time Frame: Day 28 ]
  2. Treatment success or failures will be classified according to WHO Guidelines 2005 [ Time Frame: Day 28 ]
  3. Incidence and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities [ Time Frame: Day 28 and Day 42 ]

Secondary Outcome Measures :
  1. Proportion of patients with PCR - corrected adequate clinical and parasitological response (ACPR) on Day 14 [ Time Frame: Day 14 ]
  2. Crude ACPR (non-PCR corrected ACPR) on Day 14 and Day 28 [ Time Frame: Day 14 and Day 28 ]
  3. Parasite Clearance Time [ Time Frame: Day 3 ]
  4. Fever Clearance Time [ Time Frame: Day 3 ]
  5. Proportion of patients who have cleared parasites at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ]
  6. Proportion of patients who have fever cleared at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients between the age of 3 and 60 years, inclusive.
  • Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.
  • Presence of acute uncomplicated P. falciparum mono-infection confirmed by:

    1. Fever, as defined by axillary/tympanic temperature ≥ 37.5°C or oral/rectal temperature ≥ 38°C, or documented history of fever in the previous 24 hours and,
    2. Positive microscopy of P. falciparum with parasite density between 1,000 and 100,000 asexual parasite count/μl of blood.
  • Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse.
  • Ability to swallow oral medication.

Exclusion Criteria:

  • Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization Criteria 2000.
  • Mixed Plasmodium infection.
  • Severe vomiting or severe diarrhoea.
  • Known history or evidence of clinically significant disorders.
  • Presence of significant anaemia, as defined by Hb < 8 g/dL.
  • Presence of febrile conditions caused by diseases other than malaria
  • Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, lumefantrine or artesunate or other artemisinins.
  • Patients with known disturbances of electrolytes balance, e.g., hypokalaemia or hypomagnesaemia.
  • Use of any other antimalarial agent within 2 weeks prior to start of the study as evidenced by positive urine test.
  • Female patients of child-bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures to not become pregnant during the study period.
  • Patients taking any drug which is metabolised by the cytochrome enzyme CYP2D6 (flecainide, metoprol, imipramine, amitriptyline, clomipramine).
  • Received an investigational drug within the past 4 weeks.
  • Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen. (HBsAg) or Hepatitis C antibody (HCV Ab).
  • Known seropositive HIV antibody.
  • Liver function tests [ASAT/ALAT levels] more than 2.5 times upper limit of normal range.
  • Known significant renal impairment as indicated by serum creatinine of more than 1.4 mg/dL.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00422084

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Ecole de Santé Publique, Faculté de Médecine, Université de Kinshasa
Kinshasa, DRC, Congo
Farafenni Field Station, c/o: MRC Laboratories
Fajara, Gambia
Komfo Anoykye Teaching Hospital
Kumasi, Ghana
RSUD TC Hillers
Maumere, Nusa Tenggara Timur, Indonesia, 86113
Jayapura General Hospital (RSUD) DOK II
Jayapura, Papua, Indonesia
Siaya District Hospital, Medical Superintendent's office
Siaya Town, Kenya
Malaria Research and Training Center, Faculté de Médecine, de Pharmacie et d'Ondonto-stomatologie
Bamako, Mali
Instituto Nacional de Saude, Ministero de Saude
Maputo, Mozambique
Puerto Princesa General Hospital
Puerto Princesa, Philippines
Service de Parasitologie, Faculté de Médecine, Université Cheikh Anta Diop
Dakar, Dakar Fann, Senegal
Sponsors and Collaborators
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
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Study Director: Claude Oeuvray, PhD Medicines for Malaria Venture

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Isabelle Borghini Fuhrer, Medicines for Malaria Venture Identifier: NCT00422084     History of Changes
Other Study ID Numbers: SP-C-005-06
First Posted: January 15, 2007    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008

Keywords provided by Medicines for Malaria Venture:
P falciparum

Additional relevant MeSH terms:
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Parasitic Diseases
Malaria, Falciparum
Protozoan Infections
Artemether, Lumefantrine Drug Combination
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Antiplatyhelmintic Agents