Health Condition 1: null- Plasmodium vivax malaria.
Conditions
Interventions
Intervention1: Primaquine Sustained Release Tablets: 15 mg and 30 mg tablet, o.d. for 14 and 7 days respectively
Control Intervention1: Primaquine conventional tablets: 15 mg, o.d. for 14 days
Sponsors
Ipca Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male and female patients aged 18 -65 years.2.Patients with confirmed cases of P. vivax malaria (asexual forms) by microscopy on a thin and thick blood smear with parasite count of >/=1,000/µL of blood.3.Patients with axillary temperature >/= 37.5 °C and with clinical signs and symptoms of malaria.4. Patients giving written informed consent to participate in this study.5.patients willing to undergo folloe-up for 2-6 months.
Exclusion criteria
Exclusion criteria: 1. Patients with Mixed malarial infection. 2.Patients with body weight 40 kg. 3.Patients with severe or complicated malaria. 4.Patients with glucose 6-phosphate dehydrogenase deficiency. 5.Patients with a history of dark urine or significant hemoglobinuria related to Primaquine treatment during the course of a pervious episode of malaria. 6.Patient with known history of methomoglobinemia. 7.Patients taking cardioactive drug or potentially hemolytic drugs. 8.Patients with concomitant illness (cardiac, hepatic or renal diseases-blood urea nitrogen (BUN) 20mg/dl or blood urea 40mg/dl, hepatic SGPT or SGOT 2.5 x ULN, serum bilirubin 2mg/dl and serum creatinine 1.5mg/dl)). 9. Patients previously treated with any other antimalarial therapy except chloroquine. 10.Patients showing any significant abnormality (clinical or laboratory) on pre-trial screening in the opinion of the investigator. 11. Patients with protracted vomiting and oliguria. 12.Patients with systolic BP 160 mm Hg and/or diastolic BP 110 mm Hg. 13.Patients with acute exacerbations of systemic diseases, having a tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus. 14.Patients with underlying condition compromising bone marrow function or on medication which might compromise the bone marrow. 15.Patients with history of hypersensitivity to chloroquine, primaquine or aminoquinoline derivatives, or other similar drugs. 16. Patient having any concomitant medication which may interact with study drugs. 17.Patients on another investigational drug. 18. Patients unable to tolerate oral medication and known history of alcoholism. 19.Pregnant or lactating women. 20. Women of child bearing potential. 21.Patient with methomoglobinemia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No occurrence of microscopically proven P. vivax malaria (asexual forms) after treatment with primaquine.Timepoint: Parasite count will be measured every 12 hours during 3 days of chloroquine therapy untill negative and then on day 7, 14, 21, 28 and then monthly up to 6 months. After day 14 parasite count will be measured only if the clinical signs and syptoms of malaria are present. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparative safetyTimepoint: At the end of therapy on day 14 | — |
Countries
India
Contacts
Public ContactNitin Chandurkar
Ipca Laboratories Ltd. Mumbai
Outcome results
None listed