Health Condition 1: null- acute uncomplicated Plasmodium falciparum malaria
Conditions
Interventions
Intervention1: Arterolane (RBx 11160) maleate 150 mg (3 x 50 mg tablets) and piperaquine phosphate 750 mg of Ranbaxy Laboratories Limited, India.: once daily for three days
Control Intervention1: Coar
Sponsors
Ranbaxy Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged > 12 to 65 years, inclusive. 2. Weight of the patients must be > 35 kg at screening. 3. Minimum Hemoglobin (Hb) level of > 8 gm/dl. 4. Presence of acute symptomatic uncomplicated malaria with a diagnosis confirmed by a positive blood smear with asexual forms of P. falciparum parasites only. 5. Initial parasite densities appropriate for inclusion will be between 1000 and 100,000 asexual parasites/µL blood (both inclusive). 6. Presence of fever (axillary temperature &#8805; 37.5 °C or oral &#8805; 38 °C). 7. Female patients, if of child-bearing potential must be non-lactating and willing to use contraceptive methods during the study period. 8. Written informed consent, provided by patient in accordance with local practice. If a patient is unable to provide informed consent in writing, a thumbprint to indicate consent in the presence of at least one witness is acceptable. For adolescents written informed consent, in accordance with local practice, provided by parent/guardian. If the parent/guardian is unable to write, thumb print witnessed consent is permitted. Wherever feasible, assent will also be obtained ( for patients < 18 yrs) 9. Willingness and ability to comply with the study protocol for the duration of the study. 10. Patient resides within a reasonable distance of the investigational site, so that attendance of all study visits and follow-up by medical staff are logistically feasible.
Exclusion criteria
Exclusion criteria: 1. Patients presenting with a mixed infection (i.e., malaria due to more than one causative parasite). 2. Patients with severe malaria as per WHO criteria 2000. 3. Any antimalarial treatment during 1 month prior to screening, as assessed by medical history. 4. History of hypersensitivity to artemisinins, lumefantrine, piperaquine or any other related compounds. 5. Patients who have been treated with arterolane (RBx 11160) maleate or piperaquine phosphate in any study in the past 6 months. 6. Participation in any investigational drug study during the 30 days prior to screening. 7. Electrocardiogram (ECG) abnormalities with clinical significance or relevance that require urgent management. These abnormalities include QTc interval > 450 msec at screening and cardiac conduction disorders, with the exception of right bundle branch block. 8. A female patient who is lactating or pregnant at screening. 9. Gastrointestinal dysfunction that could alter absorption or motility (e.g., diarrhea defined as > 3 episodes of watery stools in the previous 24 hours or patients who have had 3 episodes of vomiting within 24 hours prior to screening). 10. Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening: Serum creatinine &#8805; 1.5 × upper limit of normal (ULN). Aspartate transaminase > 2.5 × ULN. Alanine transaminase > 2.5 × ULN. Serum bilirubin > 3 mg/dl. 11. Patients who have had a splenectomy. 12. Patients with known history of human immunodeficiency virus (HIV) infection or other immunosuppressive disorders 13. Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric (e.g., depression, anxiety, psychosis, or schizophrenia) or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied). 14. Patients who have epilepsy or a history of convulsions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR corrected Adequate Clinical and Parasitological Response (ACPR)Timepoint: on Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with PCR-uncorrected ACPRTimepoint: Day 28;Safety parameters (Adverse events, Clinical Laboratory tests, Vital signs, Physical Examination, 12-Lead ECG)Timepoint: From Day 0 to Day 28;Fever clearance time (FCT)Timepoint: time from first dosing to first normal reading of temperature (37.5 C) for 2 consecutive normal temperature readings and a confirmed normal temperature 24 hours after the first normal body temperature reading;Gametocyte countTimepoint: Days 0, 7, 14, 21 and 28;parasite clearance timeTimepoint: time from first dosing to time of first blood draw with complete parasite clearance (parasite clearance is defined as no parasites for 2 consecutive readings 6 hours apart with a confirmed negative reading 24 hours after the first negative slide);Phrmacokinetic parameters of Cmax, Tmax, AUC, Cl.F, Vd/F, t1/2 for arterolane (RBx 11160) and piperaquineTimepoint: from day 0 to day 28 | — |
Countries
Bangladesh, India, Thailand
Contacts
Public ContactMr AS Krishna
Ranbaxy Laboratories Limited
Outcome results
None listed