NCT06379165已完成3 期
Efficacy and Safety Study of Meloxicam Nanocrystal Injection for the Treatment of Moderate to Severe Pain After Abdominal Surgery - a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled, Phase III Clinical Trial
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 192 人开始时间: 2023年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after abdominal surgery.
详细描述
In this study, a randomized, double-blind, placebo-controlled multicenter study will be conducted to evaluate the efficacy and safety of meloxicam nanocrystal injection in subjects with moderate to severe pain after 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years ≤ age ≤ 65 years, regardless of gender.
- •Elective abdominal surgery under general anesthesia.
- •ASA score of grade 1-
- •18 kg/m^2 < BMI < 30 kg/m^
- •NRS score of ≥ 4 within 3 hours after the end of surgery (last suture).
- •Able to understand the study process and the use of pain scales, and able to communicate effectively with study personnel.
- •Written informed consent signed by subject or legal representative.
排除标准
- •Abnormal liver function: ALT and/or AST > 2 × ULN, or TBIL ≥ 2 × ULN.
- •Renal impairment (blood creatinine > 1.5 × ULN), or dialysis treatment within 28 days prior to the surgery.
- •Subjects at high risk of bleeding, including subjects with congenital bleeding disorders (e.g., hemophilia), thrombocytopenic subjects (platelet count less than 50 × 10^9/L), subjects with abnormal platelet function (e.g., idiopathic thrombocytopenic purpura, disseminated intravascular coagulation, congenital abnormal platelet function), or subjects with any clinically significant active bleeding.
- •Abnormal coagulation (PT>ULN+3s and/or APTT>ULN+10s).
- •Subjects with a history of severe gastrointestinal disease (e.g. ulcers, bleeding and perforation, etc.) within 1 year prior to randomization that may be worsened by the administration of NSAIDs-like drugs.
- •Myocardial infarction or coronary artery bypass grafting within 1 year prior to randomization.
- •Abnormal clinically significant 12-lead ECG during the screening period and judged by the investigator to be inappropriate for participation in this trial.
- •Combination of severe liver, kidney, cardiovascular, cerebrovascular, or metabolic system disease, which is judged by the investigator to be inappropriate for participation in this trial.
- •Subjects with combined neurological or psychiatric disorders such as migraine and seizures, which have been judged by the investigator to affect the evaluation of the efficacy of the trial drug.
- •Subjects with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (screening period sitting systolic blood pressure ≥ 160 mmHg, and/or screening period diastolic blood pressure ≥ 100 mmHg).
- •Sitting systolic blood pressure ≤ 90 mmHg at screening.
- •Subjects with diabetes mellitus whose blood glucose is not satisfactorily controlled (random blood glucose ≥ 11.1 mmol/L during the screening period).
- •Subjects with advanced malignancy or malignancy with extensive metastases.
- •Combined with other physical pain conditions that may confound postoperative pain evaluation.
- •Subjects with known hypersensitivity to meloxicam, any of the excipients in the study drug, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs), any perioperative drug use, or other history of anaphylactic reactions.
- •Subjects with alcohol or drug dependence within 3 months prior to screening and/or subjects whose alcohol, drug, or medication withdrawal may interfere with efficacy and safety evaluations during the study period.
- •Subjects who have undergone abdominal surgery within 6 months prior to randomization.
- •Subjects who have participated in other clinical trials and received the test drug/test device within 3 months prior to randomization.
- •Subjects with contraindications to investigational drugs, standard anesthetic practices.
- •Women who are pregnant or breastfeeding.
- •Other reasons that the investigator deems inappropriate for participation in the trial.
研究组 & 干预措施
Meloxicam Nanocrystal Injection
Experimental
The eligible subjects will receive Meloxicam Nanocrystal Injection, administered as 30 mg (1 mL) every 24 h for 2 doses.
干预措施: Meloxicam Nanocrystal Injection (Drug)
Placebo
Placebo Comparator
The eligible subjects will receive Placebo, administered as 1 mL Placebo every 24 h for 2 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
PID24 (Time Weighted Sum of Pain Intensity Difference Over 24 Hours Post-Dose)
时间窗: 24 hours after first dose
The primary efficacy variable was the Pain Intensity (PI) measured by the Numerical Rating Scale (NRS); a scale from zero to 10 on which subjects circled a single number to indicate current pain level, with zero representing "No Pain" and 10 representing "Worst Possible Pain".
次要结局
- Number of times of remedial analgesia administered 0-24h and 24-48h after the first dose(0-48 hours after the first dose)
- TOTPAR (time-weighted sum of pain relief scores): TOTPAR12, TOTPAR18, TOTPAR24, TOTPAR48.(0-48 hours after the first dose)
- Proportion of subjects requiring remedial analgesia(0-48 hours after the first dose)
- The total amount of remedial analgesia used 24 h and 48 h after the first dose(0-48 hours after the first dose)
- The investigator's satisfaction score (0-4 point categorical scale score) for the subject's analgesic treatment(48 hours after the first dose)
- SPID2、SPID6、SPID12、SPID18、SPID18-24、SPID24-48、SPID42-48、SPID48(0-48 hours after the first dose)
- The subject's analgesic treatment satisfaction score (0-4 point categorical scale score)(48 hours after the first dose)
- Time to the first dose of the remedial analgesia(0-48 hours after the first dose)
研究者
研究点 (1)
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