KCT0002075已完成未知
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injection for Post-operative Pain following Laparoscopic or Robotic-assisted Laparoscopic Gastrectomy
Vivozon0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 25(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1. Patient between the ages of 25 and 70 years old, inclusive
- •2. Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
- •3. Patient experiencing immediate pain intensity(Numeric rating scale, NRS) of 5 or higher post-operation
- •4. Subject who underwent surgery specially for the clinical study
- •5. Subject who can submit a written consent form before participating in the test
- •6. Subject who can clearly communicate with the staff and the investigator
- •7. Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
排除标准
- •1. Surgical factors
- •Unplanned or emergency surgery
- •Reoperation (e.g. performing the same surgical procedure within 30 days of initial performance)
- •Subject who experiences pain associated with cancer at the surgical site prior to the surgery
- •2. Patient Characteristics
- •Premenopausal women, women of childbearing age, women currently pregnant, or capable of breastfeeding.
- •Subject diagnosed with chronic pain (e.g. on NRS (Numeric rating scale) scale of 1-10, sustained pain level of 4 or higher at ground state)
- •Subjects with psychiatric disorders that are unstable or difficult to control (e.g. untreated traumatic stress disorder, anxiety, depression)
- •*Subjects taking (the same capacity for more than 30 days) anti-depressants or anti-anxiety medications are legible for participation
- •Subjects with unstable medical conditions (e.g. subjects with unstable \angina, congestive heart failure, renal failure, liver failure, AIDS)
- •Subjects with measure of ECG(electrocardiography) QRS >200msec or QTc > 450msec during screening
- •3. Drugs, alcohol, pharmacological considerations
- •Subject swith history of drug, alcohol, opiates, or other medical abuse/dependence.
- •Subjects with unidentifiable negative results in urine examination upon drug screening
- •Subjects who made recent use of (within 30 days of operation) or are currently still making use of steroids, opioids, antipsychotic drugs
- •Subjects who consumed alcohol within 24 hours prior to surgery
- •Subjects who made use of non-narcotic analgesic (COX (cyclooxygenase)-2 inhibitor included) or non-steroidal anti-inflammatory drug (NSAID) 24 hours within operation
- •Subjects who consumed herbal supplement or nutraceutical supplements (chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, valerian etc.) within 7 days before operation
- •4. Anesthetics and other exclusion factors
- •Subjects who used neurological drugs or partial anesthesia in conjunction with surgery
- •Subjects who used parenteral administration (all) or lidocaine (>1mg/kg) during, before, after, or even 24 hours prior to the surgery
- •Subjects who have hypersensitivity to opioids
- •Subjects who have taken other investigational drugs within 30 days prior to surgery
研究者
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