NCT01982539已完成4 期
An Open-Label Study of the Safety and Efficacy of Zipsor® (Diclofenac Potassium) Liquid Filled Capsules in Pediatric Subjects (Ages 12-17 Years) With Mild to Moderate Acute Pain
Depomed0 个研究点目标入组 25 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 主要终点
- Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
研究概览
简要总结
As part of the PREA(Pediatric Research Equity Act) commitment, the objective of the study is to confirm safety and tolerability of 25 mg of Zipsor® in clinical pediatric subjects.
详细描述
Open-label study, subjects will be dosed with Zipsor® for the treatment of mild to moderate acute pain for up to 4 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects between 12-17 years of age.
- •Subjects must be post-op, having mild or moderate acute pain.
- •Other inclusions apply.
排除标准
- •Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.
- •Subject has been taking analgesic for 48-72 hours prior to Screening.
- •Subject has a history of any GI event greater than 6 months before Screening.
- •Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.
- •Subject has previously participated in another clinical study of Zipsor or taking Zipsor for any other indication.
- •Subject is requiring treatment for pre-existing hypertension.
- •Other exclusions apply.
研究组 & 干预措施
Zipsor® (Liquid filled capsules)
Experimental
25mg/every 6hrs/up to 4 days treatment
干预措施: Zipsor® (Drug)
结局指标
主要结局
Safety and Tolerability of Zipsor® in Pediatric Subjects, Ages 12 to 17 Years
时间窗: First dose to 30 days after the last dose
Safety Endpoints: * Treatment emergent AEs (TEAEs) * Serious adverse events (SAEs) * Withdrawals due to AEs * Deaths * Observed values and changes in vital sign measurements * Observed values and changes in clinical laboratory results * Physical examination findings
次要结局
- Changes in the Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.(From Baseline to 1st and 2nd hour)
- Percentage Difference of Numeric Pain Rating Scale (NPRS) Pain Score From Baseline to (1) the First Hour and (2) the Second Hour After the First Dose of Zipsor® Administration.(From Baseline to 1st and 2nd hour)
研究者
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