Ancillary Effects of Oral Naloxegol (Movantik)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Residual Urine Volume
研究概览
简要总结
The purpose of this study is to find out whether oral Naloxegol can reduce the side effects of opioid painkillers following surgery. This study aims to explore whether Naloxegol can similarly reduce opioid-induced side effects in post-surgical patients. About 130 surgery patients will participate in this study which is being conducted at Cleveland Clinic Main Campus.
详细描述
Opioids are the gold standard for postoperative pain management, but they have been shown to produce uncomfortable side effects such as urinary retention (an inability to completely empty the bladder), constipation and nausea/vomiting. Clinical evidence demonstrates that Naloxegol can safely and effectively block these undesirable side effects while maintaining the painkilling effects of opioids in outpatients suffering from opioid-induced constipation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent prior to any study specific procedures
- •Female or male aged at least 18 years
- •American Society of Anesthesiologists physical status 1-4;
- •Scheduled for elective primary hip or knee surgery under spinal anesthesia;
- •Expected to receive intravenous patient-controlled analgesia (IV PCA)
- •Expected to have significant postoperative pain
- •Negative pregnancy test
排除标准
- •Severe hepatic impairment, with/or twice the upper normal levels of liver enzymes
- •Severe renal impairment, or creatinine level > 2.0
- •History of bladder cancer
- •Patients receiving perioperative regional anesthesia blocks
- •Presence of a sacral nerve stimulator
- •Medications (anticholinergic agents such as antihistamines, phenothiazines, antidepressants, antipsychotics), conditions or comorbidity causing urinary retention
- •Patient with requirement of urinary catheter insertion before or immediately post-surgery due to immobility
- •Urinary Tract Infections and other urogenital comorbidity (incontinence, cysto-ureteric reflux, known bladder retention) or conditions which can cause urinary retention
- •Severe peptic ulcer disease, diverticular disease, infiltrative gastrointestinal tract malignancies, or peritoneal metastases
- •Patients with known or suspected disruption of blood brain barrier, which may include but not limited to: Alzheimer's disease, stroke, poliomyelitis, cerebral palsy, multiple sclerosis, spinal lesions, and Parkinson's disease
- •Gastrointestinal obstruction/Gastrointestinal perforation
- •Strong CYP3A4 inhibitors (some antibiotics, antifungals, protease inhibitors, and antidepressants), Strong CYP3A4 inducers, Other opioid antagonists
- •Hypersensitivity to MOVANTIK (naloxegol) or any of its excipients
研究组 & 干预措施
Treatment Arm
Naloxegol 25 mg given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
干预措施: Naloxegol 25 MG (Drug)
Placebo Arm
Matching placebo given once in the morning every day until Post-operative Day 3 or day of discharge whichever occurs first
干预措施: Placebo (Drug)
结局指标
主要结局
Residual Urine Volume
时间窗: from Postoperative days 1 to POD 2 or until day of discharge whichever occurs first
Residual urine volume in the bladder as assessed by bladder scan
次要结局
- Need for Indwelling Urinary Catheterization(Postoperative days 1-2 or until day of discharge whichever occurs first)
- Quality of Recovery(Postoperative Days 2 or discharge day whichever was earlier)
- Side Effects of Naloxegol on Other Opioid Related Side Effects(Postoperative days 1-2 or until day of discharge whichever occurs first)
研究者
Alparslan Turan
Principal Investigator
The Cleveland Clinic