KCT0002653终止未知
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 Total Hip Arthroplasty
Vivozon0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 20
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 65?(Year)（—）
- 性别
- All
入选标准
- •1.Patient between the ages of 25 and 65 years old
- •2.Male patient, in the case of female patient, postmenopausal women, or women physically incapable of childbearing
- •3.Subject who underwent surgery specially for the clinical study
- •4.Ability to provide written informed consent prior to any study procedures.
- •5.Ability to understand study procedures and communicate clearly with the investigator and staff.
- •6.Subjects with body weight under 100kg and body mass index (BMI) level lower than 35 kg/m2, inclusive
- •7.Single-side surgery patient
排除标准
- •1.Emergency or unplanned surgery.
- •2.Repeat operation
- •< Subject Characteristics >
- •3.Women with childbearing potential, Women who are pregnant or breastfeeding.
- •4.Unstable or poorly controlled psychiatric condition (e.g., untreated Post traumatic stress disorder, anxiety, or depression). Subjects who take stable doses of antidepressants and anti-anxiety drugs may be included.
- •5.Unstable or acute medical condition (e.g., unstable angina, congestive heart failure, renal failure, hepatic failure, AIDS).
- •6.Subjects who have long Q wave, R wave and S wave (>200msec) or prolonged Corrected QT Interval (> 450msec in male, >470msec in female) at Screening
- •< Drug, Alcohol, and Pharmacological Considerations >
- •7.History of alcohol, opiate or other drug abuse or dependence within 12 months prior to Screening .
- •8.Ongoing or recent (within 6 hour prior to surgery) use of steroids, opioids, or antipsychotics.
- •9.Alcohol consumption within 24 hours of surgery.
- •10.Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen within 6 hours of surgery.
- •11.Use of herbal agents or nutraceuticals (i.e., chaparral, comfrey, germander, jin bu huan, kava, pennyroyal, skullcap, St. John's wort, or valerian) within 7 days prior to surgery.
- •< Anesthetic and Other Exclusion Considerations >
- •12.Use of neuraxial or regional anesthesia related to the surgery.
- •13.Use of ketamine, gabapentin, pregabalin, or lidocaine (>1 mg/kg) intra or peri-operatively, or within 24 hours of surgery.
- •14.Subject with known allergies to hydromorphone.
- •15.Subjects who received another investigational drug within 30 days of scheduled surgery
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