A Phase III Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
研究概览
简要总结
Intravenous acetaminophen (IVAPAP) is safe in repeated dose, multi-day clinical use when administered at a daily dose of 40 to 75 mg/kg body weight
详细描述
To assess the safety of intravenous acetaminophen (IV APAP) when used over one or more days for the treatment of acute pain or fever in pediatric (neonates, infants, children and adolescents) inpatients who are unable to take anything by mouth (NPO), require or would benefit from IV treatment, or are willing and able to stay on IVAPAP therapy for 1 to 7 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
- 37 Weeks 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject's Parent or Guardian must provide written informed consent, with Subject assent where appropriate, prior to the Subject's participation in the Study.
- •Be less than 17 years of age and older than 37 weeks post conception
- •Anticipated by the Investigator to require multi-day (minimum of one day) use of intravenous (IV) treatment either because of a having a status of nothing by mouth (NPO) or a medical condition that makes oral intake difficult or be willing to undergo at least 5 days of treatment with IV acetaminophen for the treatment of pain or fever
- •Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff (if the Subject is of preverbal age or cannot read or communicate meaningfully, then the Subject's Parent or Guardian must meet this criterion)
- •If a female of child bearing potential, have a negative pregnancy test
排除标准
- •Has significant medical disease(s), laboratory abnormalities or condition(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation
- •Has known hypersensitivity or contraindication to receiving IV acetaminophen or the inactive ingredients (excipients) of IV acetaminophen
- •Has impaired liver function, e.g. Alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN), bilirubin greater than or equal to 3 times ULN, known active hepatic disease (e.g., hepatitis), evidence of clinically significant chronic liver disease or other condition affecting the liver (e.g., alcoholism as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV), cirrhosis, or chronic hepatitis) that may suggest the potential for an increased susceptibility to hepatic toxicity with IV acetaminophen exposure
- •Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry
研究组 & 干预措施
IV Acetaminophen
40 to 75 mg/kg/day every 4 to 6 hours
干预措施: IV Acetaminophen (Drug)
结局指标
主要结局
Number of Subjects Reporting at Least One Treatment Emergent Adverse Event (TEAE)
时间窗: First dose to end of treatment period
A TEAE is defined as an adverse event that starts on or after the start of study medication.
Number of Subjects Reporting at Least One Serious Treatment Emergent Adverse Event
时间窗: First dose to 30 days after last dose
A Serious Treatment Emergent Adverse Event is defined as any untoward medical occurrence at any dose of IV APAP that; * results in death * is life-threatening * requires inpatient hospitalization or causes prolongation of existing hospitalization * results in persistent or significant disability/incapacity * is a congenital anomaly/birth defect * is an important medical event
次要结局
- Subject's (Parent/Guardian) Global Evaluation of Study Treatment(Day 0 to Day 5, Day 7 or Early Termination from study)
- Physician's Global Assessment of Study Treatment(End of study or Early Termination)