A Phase III, Multi-Center, Open-Label, Prospective, Repeated Dose, Randomized, Controlled, Multi-Day Study of the Safety and Efficacy of Intravenous Acetaminophen in Adult Inpatients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 213
- 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
The study will be investigating safety and efficacy administration of repeated dose of IV Acetaminophen (IV APAP) over five days for the treatment of acute pain or fever in adult patients.
详细描述
• To assess the safety of IV Acetaminophen when used over five days for the treatment of acute pain or fever in adult inpatients
Secondary Objectives:
- To compare the efficacy of IV Acetaminophen 650 milligram (mg) every four (q4) hours vs. 1 gram (g) every 6 (q6) hours over 5 days of treatment
- To compare the safety of IV Acetaminophen 650 mg q4 hours vs. 1 g q6 hours over 5 days of treatment
- To compare the safety of IV Acetaminophen vs. standard of care (SOC) treatment over 5 days of treatment
- To compare the efficacy of IV Acetaminophen vs. standard of care treatment over 5 days of treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent prior to participation in the Study
- •Be at least 18 years of age and weigh at least 41 kilogram (kg)
- •Be anticipated by the Investigator to require multi-day (target is five days) use of IV treatment either because of having a "nothing by mouth" (NPO) status having a medical condition that makes oral intake difficult having a medical condition that requires IV treatment
- •Be willing to undergo 5 days of treatment with IV acetaminophen for the treatment of pain or fever (defined as a core temperature greater than or equal to 38 degrees celsius). Note that Subjects have a slightly less than 15% chance (one in seven) of being assigned to the Control Group and receiving standard of care treatment, but no IV APAP.
- •Have the ability to read and understand the Study procedures and have the ability to communicate meaningfully with the Study Investigator and staff
- •If a female of child bearing potential, have a negative pregnancy test within 48 hours of randomization
排除标准
- •Has a significant medical disease, laboratory abnormality or condition that, in the Investigator's judgment, could compromise the Subject's welfare or would otherwise contraindicate Study participation
- •Is expected to have difficulty in communicating with the Study staff or completing Study requirements (including follow up visits)
- •Has known hypersensitivity to acetaminophen or the inactive ingredients (excipients) of IV acetaminophen or any contraindication to receiving 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 DSM-IV, cirrhosis or chronic hepatitis)
- •Has participated in an interventional clinical Study (investigational or marketed product) within 30 days of Study entry
研究组 & 干预措施
1 g IV Acetaminophen
1 g q6h IV Acetaminophen
干预措施: IV Acetaminophen (Drug)
650 mg IV Acetaminophen
650 mg q4h IV Acetaminophen
干预措施: IV Acetaminophen (Drug)
Standard of Care
The standard of care treatments were defined as any medication the investigator deemed appropriate to treat the subject, including products containing acetaminophen but excluding IV acetaminophen.
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: T0 (first dose of IV APAP or randomization to SOC group) to Day 7 - 12 Follow-up
Number of subjects who experienced at least one treatment emergent adverse event (TEAE). A TEAE is an adverse event that occurs on or after the first dose of study medication (T0).
Subjects Who Experienced at Least One Serious Treatment-Emergent Adverse Event (TEAE)
时间窗: First dose (T0) to within 30 days of the last dose of study medication.
Serious TEAE is any untoward medical occurrences at any dose of study medication 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 Global Evaluation of the Level of Satisfaction With Side Effects Related to Study Treatments(End of Day 5 (prior to discharge))
- Subject Global Evaluation of the Level of Satisfaction With Study Treatments Looking Back Over the Entire Treatment Period.(Study period lookback at Day 7)