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临床试验/NCT02993861
NCT02993861已完成不适用

Pharmacokinetics of Anti-epileptic Drugs in Obese Children

Christoph P Hornik, MD MPH10 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2016年12月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
10
主要终点
Steady-state pharmacokinetics area under the curve

研究概览

简要总结

The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to characterize the pharmacokinetics and safety of four oral anti-epileptics drugs (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese children and adolescents. The study's duration will be up to eleven days (up to seven days of screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18 years will be identified through outpatient clinic schedules and inpatient admissions at each clinic site. Participants receiving at least one of the study drugs per local standard of care will have pharmacokinetic concentrations in plasma drawn according to the specific dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip ratio, medical history, concomitant medication history, documentation of study drug oral intake, adverse effects, and physical examination. The sample size will include 24 participants for each anti-epileptic drug (total 96).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 2 years to < 18 years at the time of enrollment
  • BMI ≥ 95th percentile for age and sex, based on CDC recommendations
  • Informed consent/HIPAA from the parent/legal guardian and assent (as applicable)
  • Receiving ≥ 1 of the study drugs per local standard of care

排除标准

  • Known pregnancy as determined via interview or test results, if available

结局指标

主要结局

Steady-state pharmacokinetics area under the curve

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics maximum concentration

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics time to reach maximum concentration

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics oral apparent volume of distribution

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics half life

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics oral apparent clearance

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

Steady-state pharmacokinetics absorption rate constant

时间窗: Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling)

次要结局

  • Serious adverse events(Up to 14 days (up to 7 days of screening and 7 days of pharmacokinetic sampling))

研究者

发起方
Christoph P Hornik, MD MPH
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Christoph P Hornik, MD MPH

Associate Professor of Pediatrics

Duke University

研究点 (10)

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