NCT02424578已完成2 期
A Phase IIA, Open-Label, Safety and Pharmacokinetic Study of Diclofenac Capsules in Pediatric Subjects 6 to <17 Years of Age With Mild to Moderate Acute Postoperative Pain Following Elective Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Plasma Concentration of Diclofenac
研究概览
简要总结
The purposes of this study are to evaluate the safety and tolerability and to model the single-dose pharmacokinetic profile of diclofenac capsules low dose and high dose in children ages 6 to <17 years experiencing mild to moderate acute postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body weight ≥18 kilograms.
- •Mild to moderate acute pain requiring treatment with analgesic medication.
- •Willing to have blood samples taken for PK sampling using an indwelling catheter.
- •Must be able to swallow capsules and can tolerate oral medication.
- •For females: is not of reproductive potential (defined as premenarchal) or is practicing an acceptable method of birth control
排除标准
- •Severe acute pain
- •Chronic analgesic or glucocorticoid use for any condition within 6 months before dosing with study drug.
- •Emergency surgery
- •History of allergic reaction, hypersensitivity, or clinically significant intolerance to diclofenac, aspirin, codeine, acetaminophen, or any NSAID
- •History of peptic ulcer disease or a GI event (eg, perforation, obstruction, or bleed) within 6 months before screening
- •Current use of any medication that may cause a clinically significant drug interaction when co-administered with diclofenac
- •Current use of any medication that might affect the pharmacokinetics of diclofenac
- •History of bleeding disorders .
- •Developmental delay or behavioral problems that would make it difficult to assess pain.
- •Impaired liver function
- •Clinically significant renal or cardiovascular disease
- •Any medical condition that compromises ability to swallow, absorb, metabolize, or excrete the study drug
- •Previously received any investigational product or device within 30 days before Screening or scheduled to receive an investigational device or another investigational drug (other than that in this study) during the course of this study.
- •Previous participation in this clinical study or currently taking diclofenac.
研究组 & 干预措施
Diclofenac Capsules low dose
Experimental
Diclofenac Capsules low dose three times daily for up to three days
干预措施: Diclofenac Capsules low dose (Drug)
Diclofenac Capsules high dose
Experimental
Diclofenac Capsules high dose three times daily for up to three days
干预措施: Diclofenac Capsules high dose (Drug)
结局指标
主要结局
Plasma Concentration of Diclofenac
时间窗: 0-6 hours after first dose of diclofenac
The estimated typical value for clearance (tvCl) following a single diclofenac dose based on population pharmacokinetic (PopPK) modeling using sparse plasma concentration data in pediatric subjects.
次要结局
- Safety of Diclofenac Capsules Low Dose and High Dose as Assessed by the Incidence of Adverse Events From Baseline to Day 3 or Early Termination(Baseline to Day 3/Early Termination)
研究者
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