NCT04811053已完成2 期
A Phase Ⅱ, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HR021618 in the Treatment of Moderate to Severe Pain After Abdominal Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- AUC48
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HR021618 in the treatment of 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to provide a written informed consent
- •Subjects requiring elective general anesthesia abdominal surgery
- •Male or female
- •Meet BMI standard
- •Conform to the ASA Physical Status Classification
排除标准
- •Subjects with a history of abdominal surgery
- •Subjects had hemorrhagic disorders
- •Subjects had cardiac, serious hepatic or renal, cardiovascular or cerebrovascular, metabolic, psychiatric disorders, chronic pain, or malignant tumors
- •Subjects with poor blood pressure control after medication
- •Abnormal QTc
- •Abnormal random blood glucose
- •Abnormal values in the laboratory
- •Allergic to meloxicam or any excipient of HR021618, aspirin, other non-steroidal anti-inflammatory drugs (NSAIDs) or to any peri- or postoperative medications used in this study
- •Use other drugs that affect the analgesic effect before randomization, and the time from the last use to randomization is shorter than 5 half-lives
- •Pregnant or nursing women
- •No birth control during the specified period of time
- •Participated in clinical trials of other drugs (received experimental drugs)
- •The inestigators determined that other conditions were inappropriate for participation in this clinical trial
研究组 & 干预措施
Treatment group A
Experimental
干预措施: HR021618 (Drug)
Treatment group B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
AUC48
时间窗: 48 hours after recovery from anesthesia] Area under the pain intensity-time curve.
Area under the pain intensity-time curve.
次要结局
- Anesthesiologist satisfaction rating(48 hours after recovery from anesthesia)
- Total consumption of morphine over 0-48, 0-24, 24-48 hours(48 hours after recovery from anesthesia)
- Time of the first dose of rescue analgesia(48 hours after recovery from anesthesia)
- Proportion of subjects receiving rescue analgesia(48 hours after recovery from anesthesia)
- Subjects' satisfaction rating(48 hours after recovery from anesthesia)
- Frequency of doses of rescue analgesia(48 hours after recovery from anesthesia)
- AUC3, AUC24, AUC15-21, AUC18-24, AUC24-28, AUC39-45, AUC42-48(48 hours after recovery from anesthesia)
研究者
研究点 (1)
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