A Phase III, double-blind, randomised, multicenter trial comparing the safety and efficacy of fixed dose combination tablets of arterolane maleate and piperaquine phosphate (PQP) with Coartem® (artemether-lumefantrine tablets) in patients with acute uncomplicated Plasmodium falciparum malaria
- Conditions
- Health Condition 1: null- Acute Uncomplicated Plasmodium falciparum malaria
- Registration Number
- CTRI/2009/091/000101
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1200
Patients must fulfill the following inclusion criteria to be eligible for enrollment into the study:
1. M/F patients b/w age of 12 to 65 (Both incusive)
2. B/w more than or equal to 35 kg at screening
3. presence of acute symptomatic uncomplicated malaria with confirmed diagnosis by blood smear with asexual forms of P. falciparum parasites only.
4. asexual parasites/µL in blood in patients b/w 1,000 and 100,000 (both inclusive)
5. presence of fever (axillary temperature ≥ 37.5 °C or oral ≥ 38 °C) or a documented history of fever in the past 24 hours
6. Female patients, if of child-bearing potential must be non-lactating and willing to use contraceptive methods during the study period
7. 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. For patients < 18 yrs, wherever feasible, assent will also be obtained
If any of the following conditions apply, the patient should not be enrolled in the study.
1.Patients with severe malaria as per WHO criteria1 (Appendix B).
2.Mixed infection with another Plasmodium species at the time of presentation (including P. vivax, P. ovale and P. malariae).
3.Hemoglobin (Hb) level of 8 gm/dL.
4.A female patient who is lactating or pregnant at screening.
5.Known allergy to artesunate, artemether, artemisinin derived products, lumefanterine, piperaquine or any other related drug.
6.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).
7.Use of concomitant medications that may induce haemolysis or haemolytic anaemia from the World Health Organization (WHO) list of essential drugs.
8.Any antimalarial treatment during 1 month prior to screening, as assessed by medical history.
9.Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carini pneumonia in children born to HIV+ women.
10.Participation in any investigational drug study during the 30 days prior to screening.
11.Any other underlying disease that may compromise the diagnosis and the evaluation of the response to the study medication (including clinical symptoms of immunosuppression, tuberculosis, bacterial infection; cardiac or pulmonary disease).
12.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.
13.Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening:
Serum creatinine 1.5 Ã? upper limit of normal (ULN)
Aspartate transaminase 2.5 Ã? ULN
Alanine transaminase 2.5 Ã? ULN
Serum bilirubin 3 mg/dL
14.Patients who have had a splenectomy as confirmed by history or clinical examination.
15.Patients with known history of human immunodeficiency virus (HIV) infection or other immunosuppressive disorders.
16.Evidence of clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, or endocrine diseases, malignancy, or other abnormalities (other than the indication being studied) that may compromise the diagnosis and the evaluation of the response to the study medication.
17.Patients who have epilepsy or a history of convulsions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method