CTRI/2010/091/000245
Completed
Phase 3
Comparative Evaluation of Efficacy and Safety of Primaquine SR Tablets Vs Primaquine Conventional Tablets in the Prevention of Relapse of Plasmodium Vivax Malaria.
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Ipca Laboratories Ltd
- Enrollment
- 360
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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