A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Analgesic Efficacy, Safety and Tolerability of Meloxicam Injection in Subjects After Abdominal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
研究概览
简要总结
The purpose of this study is to determine the analgesic efficacy and safety of Meloxicam Injection in subjects undergoing abdominal 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily provide written informed consent. Be scheduled to undergo elective abdominoplasty surgery without collateral procedures.
- •Be American Society of Anesthesiology (ASA) physical class 1 or
- •Male or female between 18 and 70 years of age, inclusive. Have a body mass index 18~30 kg/m
- •Be able to understand the study procedures, comply with all study procedures, and agree to participate in the study program.
排除标准
- •Have a history of abdominoplasty surgery within the preceding 12 months. Have active or recent (within 6 months) gastrointestinal ulceration or bleeding.
- •Have a history of myocardial infarction or coronary artery bypass graft surgery within the preceding 12 months.
- •Have a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study.
- •Have a history of migraine or frequent headaches, seizures, or are currently taking anticonvulsants.
- •Have another painful physical condition that may confound the assessments of post operative pain.
- •Have a history of advanced malignant tumor. Have a history of alcohol abuse (regularly drinks > 4 units of alcohol per day; 8 oz. beer, 3 oz. wine, 1 oz. spirits) within the past 5 years or a history of prescription/illicit drug abuse.
- •Have positive results on the urine drug screen or alcohol breath test indicative of illicit drug or alcohol abuse.
- •Have evidence of a clinically significant 12 lead ECG abnormality. Have a clinically significant abnormal clinical laboratory test value. Have history of or positive test results for HIV, treponema pallidum,or hepatitis B or C.
- •Have a known allergy to meloxicam or any excipient of N1539, D5W, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study.
- •Have been receiving or have received chronic opioid therapy defined as greater than 15 morphine equivalents units per day for greater than 3 out of 7 days per week over a one-month period within 12 months of surgery.
研究组 & 干预措施
meloxicam injection 30 mg
meloxicam injection 30mg every 24 hours for up to 2 doses.
干预措施: Meloxicam Injection 30mg (Drug)
meloxicam injection 60 mg
meloxicam injection 60mg every 24 hours for up to 2 doses
干预措施: Meloxicam Injection 60mg (Drug)
IV Placebo
IV Placebo every 24 hours for up to 2 doses
干预措施: Nacl 0.9% (Drug)
结局指标
主要结局
Summed Pain Intensity Difference Over the First 24 Hours (SPID24)
时间窗: 24 Hours
Pain intensity was recorded using a Numeric Pain Rating Scale (Range 0-10) where 0 equates to no pain (better), and 10 equates to the worst pain imaginable (worse). Pain intensity scores were to be recorded at the following time points: 0.25, 0.5, 0.75, 1, and 2 hours post Dose 1. Thereafter pain assessments were to be recorded every 2 hours until 48 hours post Dose 1. Pain intensity differences from baseline at each time point were calculated and a time weighted summed pain intensity difference (SPID) was then calculated. Time weighted SPID calculations were computed by multiplying a weight factor to each score prior to summation. The weight factor at each time point was the time elapsed since the previous observation. A smaller SPID value (i.e. more negative) was better.
次要结局
- Time to First Dose of Rescue Analgesia(48 Hours)
- Number of Subjects Utilizing Rescue Analgesia(48 Hours)
- Summed Pain Intensity Difference (SPID) at Other Intervals(48 Hours)