Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 331
- 试验地点
- 27
- 主要终点
- Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
研究概览
简要总结
This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.
详细描述
The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
- •18-75 years of age
- •Body Mass Index (BMI) between 19-45
- •American Society of Anesthesiologists (ASA) risk class of I, II, III
- •Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
- •Moderate to Severe pain at rest
排除标准
- •Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
- •Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
- •Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
- •Known history of alcohol or drug abuse or misuse
- •Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
- •Has significant medical disease(s), or conditions that may contraindicate participation in the study
- •Has participated in another clinical trial within 30 days of surgery
研究组 & 干预措施
IV acetaminophen 1 g/100 mL solution
干预措施: IV Acetaminophen (Drug)
IV Placebo 100 mL solution
干预措施: IV Placebo 100 mL solution (Drug)
结局指标
主要结局
Sum of Pain Intensity at Rest-Baseline to 24 Hours (SPI24rest), 1 Gram IV Acetaminophen vs. Placebo.
时间窗: Baseline (just prior to the first dose) through 24 hours
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 24 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 24 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-2400 mm for 24 hours.
Sum Pain Intensity at Rest-Baseline to 48 Hours (SPI48rest), 1 Gram IV Acetaminophen vs. Placebo
时间窗: Baseline (just prior to the first dose) through 48 hours
The Sum of Pain Intensity (SPI) score incorporates the analgesic effects on pain intensity (PI) from Baseline to 48 hours. SPI was measured by the 100 millimeter (mm) long Visual Analog Scale (VAS) over 48 hours after treatment. Subjects were asked to mark the level of pain they were experiencing at a certain timepoint on the scale The 100 mm VAS scale was used with the left terminus (0 mm) of the scale "No Pain" and the right terminus (100 mm) with "Worst Pain Imaginable". The range of measurement is 0-4800 mm for 48 hours.
次要结局
- Subjects Who Experienced at Least One Treatment-emergent Serious Adverse Event.(32 days following first dose of study medication.)
- Subjects Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)(First dose through 7 day follow up)