A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Acceleration of gastrointestinal recovery
研究概览
简要总结
Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).
详细描述
Postoperative ileus (POI) is a temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection or hysterectomy.
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
- Double
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
- •Subject is scheduled for a partial small/large bowel resection with primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
- •Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids
排除标准
- •Subject is scheduled for a total colectomy, colostomy, ileostomy
- •Subject has complete bowel obstruction
- •Subject has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery Subject has been on chronic (>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery.
结局指标
主要结局
Acceleration of gastrointestinal recovery
次要结局
- Time until discharge order is written
- Time until ready for discharge based upon recovery of GI function
- Time to tolerate liquids
- Severity of GI symptoms
- Pain
- Opioid Consumption
- Need for reinsertion of nasogastric tube