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1 Clinical Trial Details (PDF Generation Date :- Mon, 24 Dec :44:40 GMT) CTRI Number CTRI/2009/091/ [Registered on: 16/12/2009] - Last Modified On 05/12/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial 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 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) R Designation Affiliation Protocol Number Details of Principal Investigator Dr Nilanjan Saha Sponsors Representative Phone Fax Designation Affiliation Department of Medical Affairs and Clinical Research Ranbaxy Laboratories Ltd R&D IV 77B Sector 18 Gurgaon HARYANA nilanjan.saha@ranbaxy.com Details Contact Person (Scientific Query) Dr Nilanjan Saha Ranbaxy Laboratories Limited Phone Fax Designation Affiliation Department of Medical Affairs and Clinical Research, Ranbaxy Laboratories Ltd., R&D IV, 77-B, Sector 18 Gurgaon HARYANA Haryana nilanjan.saha@ranbaxy.com Details Contact Person (Public Query) Dr Nilanjan Saha Sponsor Representative Department of Medical Affairs and Clinical Research, Ranbaxy Laboratories Ltd R&D IV 77B Sector 18 Gurgaon page 1 / 6

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee HARYANA Phone Fax > Ranbaxy Laboratories Ltd. INDIA Source of Monetary or Material Support Primary Sponsor Details Ranbaxy Laboratories Ltd Plot No. 20, Sector 18 Udyog Vihar Industrial Area Gurgaon Haryana INDIA Type of Sponsor Pharmaceutical industry-global Department of Science and Tecnology Govt Of List of Countries Cote d'ivoire Democratic Republic of the Congo Mali Mozambique Senegal Thailand of Principal Investigator Dr. TK Bose Dr. BHK Rao of Site Site Phone/Fax/ Community Welfare Society Hospital, Rourkela, Orissa Government Wenlock District Hospital, Mangalore, Karnataka Jagda, Rourkela, Not Applicable N/A, Bangalore KARNATAKA Dr Sanjib Mohanty Ispat General Hospital, Rourkela (Orissa), Sundargarh ORISSA Dr. B Shahi Dr. BS Rao Mahadevi Birla Hospital & Research Center, Mahilong, Nankum, Ranchi, Jharkhand Tata main Hospital, Department of Medicine, Jamshedpur, Jharkhand,- Ranchi JHARKHAND, Not Applicable N/A cwshnimr@gmail.com raobhk@yahoo.co.in sanjibmalaria@rediffma il.com shahibh@yahoo.co.in dr_bsrao@tatasteel.co m of Committee Approval Status Date of Approval Is Independent Ethics Committee? Comite National D Ethique pour la Recherche en Sante, Senegal Approved 06/07/2011 Yes Comite National Approved 28/02/2011 Yes page 2 / 6

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent dethique et de Recherche (CNER) de Côte divoire Convite nacional De Bioetica Para A Saude, Mozambique DEthique De La FMPOS, Mali Ecole De sante publique Convite D Ethique DR Congo Ethical Review Committee, Chittagong Medical College, Bangladesh Ethics Committee of Faculty of Tropical medicine Mahidol University, Thailand Committee for Tata Main Hospital, Jamshedpur Committee, CWS Hospital, Jagda, Rourkela Committee, Ispat General Hospital, Orrisa Committee, Kasturba Medical College, Mangalore Committee, National Institute Of Malaria Research (ICMR) For Mahadevi Birla Hospital & Research Center, Ranchi Pharmacy, Medicines and Poisons Board, Malawi Status Approved/Obtained Health Type Patients Approved 03/03/2011 Yes Approved 06/04/2011 Yes Approved 19/12/2011 Yes Approved 21/08/2010 Yes Approved 03/08/2009 Yes Approved 05/11/2009 Yes Approved 22/08/2009 Yes Approved 25/08/2009 Yes Approved 03/09/2009 Yes Approved 03/07/2009 Yes Approved 03/08/2012 Yes Date No Date Specified Condition Acute Uncomplicated Plasmodium falciparum malaria Type Details Intervention Fixed dose combination (FDC) tablets of arterolane maleate 150 mg and PQP 750 mg of Ranbaxy Laboratories Limited, for oral administration once daily for three days page 3 / 6

4 Inclusion Criteria Exclusion Criteria Comparator Agent Age From Age To Gender Details Details Coartem tablets (each tablet containing artemether 20 mg and lumefantrine 120 mg in FDC) of Novartis for oral administration Inclusion Criteria Six dose treatment as a single dose of four tablets at the time of initial diagnosis followed by four tablets after eight hours then four tablets twice daily (morning and evening) on each of the following days 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 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). 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). page 4 / 6

5 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 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. Method of Generating Random Sequence Method of Concealment Blinding/Masking Permuted block randomization, fixed Centralized Double Blind Double Dummy Primary Outcome Outcome Timepoints Proportion of patients with PCR corrected ACPR On Day 28 Secondary Outcome Outcome Timepoints Target Sample Size Parasite Clearance Time (PCT) Fever Clearance Time (FCT) Proportion of patients with PCR-uncorrected ACPR Proportion of patients with PCR-uncorrected ACPR Time in hours from initiation of therapy until first of the two consecutive negative smears are obtained 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 Day 28 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 Pk parameters: Cmax, Tmax, AUC, CL/F, Vd/F, t1/2 and additional PK model dependant parameter Total Sample Size=1200 Sample Size from =202 Phase of Trial Phase 3/ Phase 4 Date of First Enrollment () 20/11/2009 Days 0,1,2,3,7,14,21,28,35 and 42 Days 0,1,2,7,14,21,28,35 and 42 page 5 / 6

6 Powered by TCPDF ( PDF of Trial Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 09/11/2009 Years=2 Months=0 Days=0 Completed Completed not yet This multicenter, double blind, Phase III study (R ) 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; (Ranchi, Rourkela -2 sites, Jamshedpur and Mangalore) Bandarban, Bangladesh. Six new sites has been initiated in Africa: Ivory Coast, Senegal, Mali, DRC (2 Sites), Mozambique. A total of 350 patients have been enrolled in Africa till date ( ) page 6 / 6