NCT06932107已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection(QLG2174) in the Prevention of Post-operative Nausea and Vomiting
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 518
- 试验地点
- 1
- 主要终点
- Complete response (CR) rates over 24 hours after the end of surgery
研究概览
简要总结
The goal of this Interventional study is to evaluate the efficacy and safety of Aprepitant Injection(QLG2174) for preventing PONV in Chinese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •aged 18 to 70 years, with a body mass index (BMI) of 18-30 kg/m² and body weight≥45kg.
- •laparoscopic gynecologic or abdominal surgery under general anesthesia (duration≥1 hour and postoperative hospitalization ≥24 hours), with anesthesia maintained using sevoflurane and remifentanil (propofol maintenance was prohibited);
- •had≥2 risk factors of PONV; expected to use postoperative opioid within 24 hours after surgery;
- •American Society of Anesthesiologists (ASA) physical status class I-III.
排除标准
- •planned intrathoracic, transplant, or central nervous system surgeries;
- •diagnostic-only procedures;
- •use of local/regional anesthesia (e.g., neuraxial/nerve blocks);
- •postoperative intensive care unit (ICU) transfer;
- •preoperative nasogastric/orogastric tube placement (from screening through 24 hours postoperatively)
- •nausea, vomiting, retching, or organic disease-related emesis (e.g., intestinal obstruction) within 24 hours preoperatively; history of malignancy, epilepsy, or vestibular dysfunction;
- •hypersensitivity to aprepitant;
- •recent use of aprepitant/NK1 antagonists (within 2 weeks prior to randomization), antiemetics (including 5-HT3 antagonists, corticosteroids; within 1 week), strong CYP3A4 inhibitors/substrates (within 1 week), CYP3A4 inducers (within 4 weeks), or warfarin (within 2 weeks);
- •clinically significant laboratory abnormalities (ALT/AST ≥2×upper limit of normal [ULN], total bilirubin ≥1.5×ULN, creatinine ≥1.5×ULN, hemoglobin ≤90 g/L)
研究组 & 干预措施
Aprepitant Injection
Experimental
干预措施: Aprepitant Injection (Drug)
Aprepitant Injection Placebo
Experimental
干预措施: Aprepitant Injection Placebo (Drug)
结局指标
主要结局
Complete response (CR) rates over 24 hours after the end of surgery
时间窗: 0-24 hours after the end of surgery
Complete response (defined as no emetic episodes and no use of rescue therapy
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B VaccineHepatitis B, ChronicNCT04289987CHA Vaccine Institute Co., Ltd.134
已完成
3 期
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With SchizophreniaSchizophreniaNCT00334126Johnson & Johnson Pharmaceutical Research & Development, L.L.C.399
已完成
2 期
MK0249 for the Symptomatic Treatment of Alzheimer's Disease (MK0249-011)Alzheimer's DiseaseNCT00420420Merck Sharp & Dohme LLC144
已完成
2 期
Efficacy-safety Study of Sublingual Immunotherapy With Depigmented-polymerized Pollen Extracts to Treat RhinoconjunctivitisAllergic RhinoconjunctivitisNCT00550875Laboratorios Leti, S.L.90
Unknown
不适用
Study to Assess the Efficacy of Intralesional Corticosteroid on the Treatment of Frontal Fibrosing AlopeciaFrontal Fibrosing AlopeciaNCT02467101Rubina Alves10