CTRI/2007/091/000031已完成2 期
A phase II, randomized, open label, multicentre study to assess the antimalarial efficacy and safety of arterolane (RBx 11160) maleate and piperaquine phosphate coadministration and Coartem® in patients with acute uncomplicated Plasmodium falciparum malaria
Ranbaxy Laboratories Ltd0 个研究点目标入组 240 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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 ≥ 37.5 °C or oral ≥ 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.
排除标准
- •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 ≥ 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.
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