SAFETY & PHARMACOKINETIC STUDY OF TOMOXETINE HYDROCHLORIDE IN PEDIATRICS

这项研究的主要目标是评估盐酸托莫西汀在被诊断为DSM-IV定义的注意缺陷多动障碍的儿童患者中的安全性和有效性。盐酸托莫西汀的血浆浓度提供了药物在体内存在的测量。本研究的目的是将儿科患者的稳态血药浓度和药代动力学与成人患者的稳态血药浓度和药代动力学进行比较。在这项研究中收集的信息将允许评估在儿童患者中达到与成人患者相同的稳态血浆浓度所需的剂量修改，并将确定在减少注意缺陷多动障碍症状方面提供最大治疗益处的剂量范围。初步发现包括托莫西汀对儿童注意缺陷多动障碍症状的强大有效性，以及令人放心的安全性和耐受性数据。在该方案的11周剂量范围内，研究人员能够建立~2 mg/kg的最佳有效剂量。对药代动力学数据的初步分析显示，托莫西汀在成人体内的药动学曲线与药物动力学曲线非常相似。这些数据使托莫西汀的大型工业赞助对照试验得以设计。

The primary objectives of this tudy are to evaluate the safety and effectiveness of tomoxetine hydrochloride in pediatric patients who have been diagnosed with attention deficit-hyperactivity disorder as defined by the DSM-IV. Plasma concentrations of tomoxetine hydrocloride provide a measurement of the presence of the drug in the body. An aim of this study is to compare the steady-state plasma concentrations achieved and pharmacokinetics attained in pediatric patients, to the steady-state plasma concentrations achieved, and pharmacokinetics attained in adult patients from prior pharmacokinetic studies. The information collected in this study will permit an assessment of dosage modification necessary to achieve steady-state plasma concentrations in pediatric patients corresponding to those achieved in adult patients, and will identify a dose range that provides maximum therapeutic benefit in the reduction of symptoms of attention deficit-hyperactivity disorder. Preliminary findings include robust effectiveness of tomoxetine for attention deficit-hyperactivity disorder symptoms in children, as well as reassuring safety and tolerability data. In the 11 week, dose ranging arm of the protocol, the investigators were able to establish an optimal effective dose of ~2 mg/kg. A preliminary analysis of the pharmacokinetic data reveals a close parallel to the phaarmacokinetic profile of tomoxetine in adults. This data has permitted the design of a large, industry sponsored controlled trial of tomoxetine.