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

This study has been completed.
Sponsor:
Collaborator:
Shin Poong Pharmaceuticals
Information provided by:
Medicines for Malaria Venture
ClinicalTrials.gov Identifier:
NCT00422084
First received: January 12, 2007
Last updated: May 19, 2008
Last verified: May 2008

January 12, 2007
May 19, 2008
January 2007
April 2008   (final data collection date for primary outcome measure)
  • PCR-corrected adequate clinical and parasitological response (ACPR) rate on Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • Treatment success or failures will be classified according to WHO Guidelines 2005 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • PCR-corrected adequate clinical and parasitological response (ACPR) rate on Day 28
  • Treatment success or failures will be classified according to WHO Guidelines 2005
  • Incidence and severity of adverse events and of clinically significant laboratory results, ECG, vital signs or physical examination abnormalities
Complete list of historical versions of study NCT00422084 on ClinicalTrials.gov Archive Site
  • Proportion of patients with PCR - corrected adequate clinical and parasitological response (ACPR) on Day 14 [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
  • Crude ACPR (non-PCR corrected ACPR) on Day 14 and Day 28 [ Time Frame: Day 14 and Day 28 ] [ Designated as safety issue: No ]
  • Parasite Clearance Time [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Fever Clearance Time [ Time Frame: Day 3 ] [ Designated as safety issue: No ]
  • Proportion of patients who have cleared parasites at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Proportion of patients who have fever cleared at Day 1, 2 and 3 [ Time Frame: Days 1, 2, 3 ] [ Designated as safety issue: No ]
  • Proportion of patients with PCR - corrected adequate clinical and parasitological response (ACPR) on Day 14
  • Crude ACPR (non-PCR corrected ACPR) on Day 14 and Day 28
  • Parasite Clearance Time
  • Fever Clearance Time
  • Proportion of patients who have cleared parasites at Day 1, 2 and 3
  • Proportion of patients who have fever cleared at Day 1, 2 and 3
Not Provided
Not Provided
 
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Malaria
  • Drug: Pyronaridine artesunate
    once a day for 3 days
    Other Name: Pyramax
  • Drug: Coartem® (artemether lumefantrine)
    twice a day for 3 days
    Other Name: Coartem
  • Experimental: 1
    Pyronaridine artesunate
    Intervention: Drug: Pyronaridine artesunate
  • Active Comparator: 2
    Arthemether lumefantrine
    Intervention: Drug: Coartem® (artemether lumefantrine)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1269
May 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
3 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Congo,   Gambia,   Ghana,   Indonesia,   Kenya,   Mali,   Mozambique,   Philippines,   Senegal
 
NCT00422084
SP-C-005-06
Not Provided
Isabelle Borghini Fuhrer, Medicines for Malaria Venture
Medicines for Malaria Venture
Shin Poong Pharmaceuticals
Study Director: Claude Oeuvray, PhD Medicines for Malaria Venture
Medicines for Malaria Venture
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP