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
Phase 3
Completed
- Conditions
- Acute Uncomplicated Plasmodium falciparum malaria
- Registration Number
- CTRI/2009/091/000101
- Lead Sponsor
- Ranbaxy Laboratories Ltd
- Brief Summary
This multicenter, double blind, Phase III study (R11160083002) to compare fixed dose combination of arterolane maleate (150 mg) and PQP (750 mg) with Coartem® in adult malaria patients is ongoing.A total of 327 patients had completed the trial at 7 sites: Bangkok, Thailand; India (Ranchi, Rourkela -2 sites, Jamshedpur and Mangalore) Bandarban, Bangladesh. Six new sites has been initiated in Africa: xml:namespace prefix = st1 ns = "urn:schemas-microsoft-com:office:smarttags" /Ivory Coast, Senegal, Mali, DRC (2 Sites), Mozambique. A total of 350 patients have been enrolled in Africa till date (17.05.2012)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1200
Inclusion Criteria
- 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 screening3.
- 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 hours6.
- 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.
Exclusion Criteria
- 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).
- ovale and P.
- 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.
- 13.Patients with known significant renal or hepatic impairment indicated by the following laboratory evaluations at screening: Serum creatinine 1.5 × upper limit of normal (ULN) Aspartate transaminase 2.5 × ULN Alanine transaminase 2.5 × 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 Proportion of patients with PCR corrected ACPR On Day 28
- Secondary Outcome Measures
Name Time Method Parasite Clearance Time (PCT) Time in hours from initiation of therapy until first of the two consecutive negative smears are obtained Fever Clearance Time (FCT) 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 Proportion of patients with PCR-uncorrected ACPR Day 42 Proportion of patients with PCR corrected ACPR Day 42 Proportion of aparasitemic patients Days 1, 2 and 3 Number of gametocytes Days 0,1,2,3,7,14,21,28,35 and 42 safety endpoints: Incidence of adverse events, lab parameters, physical examination, ECG or vitals Days 0,1,2,3,7,14,21,28,35 and 42 Pk parameters: Cmax, Tmax, AUC, CL/F, Vd/F, t1/2 and additional PK model dependant parameter Days 0,1,2,7,14,21,28,35 and 42
Trial Locations
- Locations (5)
Community Welfare Society Hospital, Rourkela, Orissa
🇮🇳Jagda,, Rourkela,, India
Government Wenlock District Hospital, Mangalore, Karnataka
🇮🇳Bangalore, KARNATAKA, India
Ispat General Hospital,
🇮🇳Sundargarh, ORISSA, India
Mahadevi Birla Hospital & Research Center, Mahilong, Nankum, Ranchi, Jharkhand
🇮🇳Ranchi, JHARKHAND, India
Tata main Hospital, Department of Medicine, Jamshedpur, Jharkhand
🇮🇳India
Community Welfare Society Hospital, Rourkela, Orissa🇮🇳Jagda,, Rourkela,, IndiaDr. TK BosePrincipal investigatorcwshnimr@gmail.com