NCT04699175Unknown2 期
A Phase Ⅱ, Multicenter, Randomized, Single-Blind, Placebo-Controlled, Evaluation of the Safety, Efficacy of HR021618 for Pain Management Following Orthopaedic Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Usage of Morphine, Post Surgery
研究概览
简要总结
The study is being conducted to evaluate the efficacy, safety of HR021618 and to explore the reasonable dosage of HR021618 for Pain Management after Orthopaedic 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
- •Able and willing to provide a written informed consent
- •Subjects requiring elective Orthopaedic surgery
- •Male or female
- •Meet the weight standard
- •Conform to the ASA Physical Status Classification Postoperative randomization criteria Exclusion Criteria
- •1、 Sufficient pain to require IVanalgesia assessed by NRS ranging 2、 No evidence of organ insufficiency, or any other abnormality, during or following surgery
排除标准
- •History of major surgery
- •History of active or high-risk bleeding disorders
- •History of myocardial infarction or coronary artery bypass
- •History or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, or other condition that would preclude participation in the study
- •Abnormal values in the laboratory
- •Have a known allergy 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
- •Planned/actual admission to the intensive care unit
- •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 C
Placebo Comparator
干预措施: Placebo (Drug)
Treatment group B
Experimental
干预措施: HR021618 (Drug)
Treatment group A
Experimental
干预措施: HR021618 (Drug)
结局指标
主要结局
Usage of Morphine, Post Surgery
时间窗: 0 hour to 24 hours after IP administration
Change in the amount of morphine use (in milligrams) by subjects in each treatment group for a 24 hour period post IP administration.
次要结局
- Patient Global Assessment (PGA) of Pain Control(0 hour to 48 hours after IP administration)
- Proportion of subjects who received Rescue Analgesia(0 hour to 48 hours after IP administration)
- Usage of Morphine, Post Surgery at other intervals(0 hour to 48 hours after IP administration)
- Pain relief assessed using an 5-point likert scale(Baseline till 48 hours post IP administration)
- Frequency of Doses of Rescue Analgesia Utilized Per Subject(0 hour to 48 hours after IP administration)
- Pain intensity assessed using an 11-point NRS ranging(Baseline till 48 hours post IP administration)
- Time to First Dose of Rescue Analgesia(0 hour to 48 hours after IP administration)
研究者
研究点 (1)
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