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Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria

NCT01594931 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 477

Last updated 2021-11-02

Study results available
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Summary

The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

DRUG

pyronaridine/artesunate

Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Sornchai Looareesuwan, MD · Hospital of Tropical Diseases, Mahidol University, Bangkok, Thailand

  • Duong Socheat, MD · Nat. Centre for Parasitol., Entomol. and Malaria Control, Phnom Penh, Cambodia

  • Emiliana Tjitra, PhD · Bethesda Hospital, Tomohon, North Sulawasi, Indonesia

  • Kalifa Bojang, MD · MRC Laboratories, Faraffeni, The Gambia

  • Patrice Piola, MD · Epicentre, Mbarara, Uganda

  • Oumar Gaye, MD · Centre de santé Roi Baudouin, Guediawaye, Senegal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-03-31
Completion
2006-04-30

Countries

  • Cambodia
  • Indonesia
  • Senegal
  • Thailand
  • The Gambia
  • Uganda

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01594931 on ClinicalTrials.gov