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Last Updated: April 22, 2024

CLINICAL TRIALS PROFILE FOR PRIMAQUINE PHOSPHATE


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All Clinical Trials for Primaquine Phosphate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00158587 ↗ Eight Week Primaquine Regimen for the Treatment of Vivax Malaria Completed HealthNet TPO Phase 3 2004-04-01 Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗ Eight Week Primaquine Regimen for the Treatment of Vivax Malaria Completed Gates Malaria Partnership Phase 3 2004-04-01 Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00158587 ↗ Eight Week Primaquine Regimen for the Treatment of Vivax Malaria Completed London School of Hygiene and Tropical Medicine Phase 3 2004-04-01 Plasmodium vivax represents a major health problem throughout the tropics. Outside Africa it accounts for over 50% of cases, affecting an estimated 70-80 million people per year. A substantial proportion of clinical cases are not caused by infective bites of Anopheles spp, but by activation of latent hypnozoites in the liver. These relapses may significantly impede development since each illness may result in 5-15 days of absence from work or school. Primaquine(PQ) is the only drug available that eliminates hypnozoites, though its use is beset by clinical problems; it may precipitate haemolytic anaemia in individuals deficient in the blood enzyme glucose 6 phosphate dehydrogenase (G6PD). Without affordable G6PD testing, primaquine use is precluded. Evidence suggests, however, that a course of 8 weekly doses may be a safe and effective alternative to the traditional 14 day course of the drug. The aim of the proposed study, therefore, is to test whether 8 weekly doses of primaquine is as effective as the 14 day course at preventing relapse malaria, without the risk of hemolysis in G6PD deficient individuals.
NCT00440999 ↗ Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria Completed Shin Poong Pharmaceuticals Phase 3 2007-03-01 The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
NCT00440999 ↗ Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria Completed Medicines for Malaria Venture Phase 3 2007-03-01 The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax malaria.
NCT01178021 ↗ Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan Completed Mahidol University Phase 4 2009-08-01 This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
NCT01178021 ↗ Estimating the Risk of Plasmodium Vivax Relapses in Afghanistan Completed National Malaria and Leishmaniasis Control Program, Afghanistan Phase 4 2009-08-01 This is an open label two-arm randomized prospective study of two treatments for P. vivax malaria. Patients meeting study inclusion criteria will be enrolled and allocated either chloroquine alone or chloroquine plus primaquine (0.25mg/kg/day for 14 days). Patients will be followed-up for 1 year, with clinical and laboratory examinations at each visit. Patients with recurrent P. vivax infection will be treated with the same medication as initially randomized unless contraindicated. Recurrences in the two arms will be compared to estimate the risk of and mean duration to relapse, classify the relapse pattern as early or late relapse and to estimate the efficacy and safety of the study drugs. Polymerase Chain Reaction (PCR) analysis will be used as far as possible help to distinguish between relapse and re-infection. Samples for chloroquine pharmacokinetic analysis will be collected on day 7 from each study subject as well as on the day of recurrence if within 8 weeks of chloroquine
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Primaquine Phosphate

Condition Name

Condition Name for Primaquine Phosphate
Intervention Trials
Malaria 13
Vivax Malaria 6
Malaria, Vivax 5
Healthy 5
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Condition MeSH

Condition MeSH for Primaquine Phosphate
Intervention Trials
Malaria 27
Malaria, Vivax 14
Malaria, Falciparum 5
Glucosephosphate Dehydrogenase Deficiency 5
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Clinical Trial Locations for Primaquine Phosphate

Trials by Country

Trials by Country for Primaquine Phosphate
Location Trials
Thailand 12
Brazil 7
Indonesia 6
Afghanistan 4
Ethiopia 4
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Trials by US State

Trials by US State for Primaquine Phosphate
Location Trials
Mississippi 1
California 1
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Clinical Trial Progress for Primaquine Phosphate

Clinical Trial Phase

Clinical Trial Phase for Primaquine Phosphate
Clinical Trial Phase Trials
Phase 4 11
Phase 3 9
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Primaquine Phosphate
Clinical Trial Phase Trials
Completed 29
Not yet recruiting 5
Recruiting 2
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Clinical Trial Sponsors for Primaquine Phosphate

Sponsor Name

Sponsor Name for Primaquine Phosphate
Sponsor Trials
University of Oxford 13
London School of Hygiene and Tropical Medicine 8
Medicines for Malaria Venture 4
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Sponsor Type

Sponsor Type for Primaquine Phosphate
Sponsor Trials
Other 92
Industry 4
U.S. Fed 2
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