NCT07709598招募中2 期
A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Parallel-Group Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of HL-1186 Tablets for Postoperative Analgesia in Abdominal Surgery
Shanghai Huilun Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 330 人开始时间: 2026年5月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- SPID48
研究概览
简要总结
This clinical trial is a multiple-center, randomized, double-blind, placebo- and active-controlled parallel-group Phase II/III clinical trial, to evaluate the efficacy and safety of HL-1186 Tablets for Postoperative Analgesia in 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 75 years old, gender is not limited.
- •18 kg/m2 ≤ Body Mass Index (BMI) ≤ 30kg/m
- •Scheduled to undergo abdominal surgery under general anesthesia, with expected moderate-to-severe postoperative pain intensity.
- •Able to understand the research process and the use of pain scales, and communicate effectively with researchers.
- •After surgery completion, the participant is judged by the investigator to be awake and has a resting NRS score ≥ 4.
排除标准
- •Previous surgery on the same site that may affect pain perception at the surgical site.
- •Paresthesia or other pain that may affect postoperative pain evaluation or scale assessment.
- •Neuropsychological disorders that may affect postoperative pain evaluation or scale assessment.
- •Unstable angina, myocardial infarction, severe arrhythmia, NYHA cardiac function class ≥ III, or recurrent asthma attacks, etc., deemed unsuitable for inclusion by the investigator.
- •Poorly controlled hypertension.
- •Sleep apnea syndrome, or the presence of a difficult airway as assessed by the investigator.
- •Known allergy to any component of the investigational drug(s), to perioperative (from induction of anesthesia to completion of surgery) anesthetic/analgesic/antiemetic drugs, or a history of allergy to ≥ 3 substances.
- •Positive for human immunodeficiency virus (HIV) antibody; positive for Treponema pallidum antibody and positive toluidine red unheated serum test (TRUST); positive for hepatitis B surface antigen (HBsAg) with detectable HBV-DNA; or positive for hepatitis C virus (HCV) antibody.
- •Women who are pregnant or breastfeeding (within 1 year after delivery).
- •Participation in another drug or medical device trial within 1 month before screening, or currently participating in another clinical trial receiving investigational intervention.
- •Any other condition considered unsuitable for participation by the investigator.
结局指标
主要结局
SPID48
时间窗: 0 to 48 hours
SPID48: Time-weighted Sum of the Pain Intensity Difference (SPID) as recorded on an NRS (Numeric Rating Scale, 0 =no pain to 10 =worst possible pain) at rest 0 to 48 hours after the first dose of study drug. The score range was -480 (worst score) to 480 (best score).
次要结局
- Number of participants with treatment-related adverse events(0-9 days)
研究者
研究点 (1)
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