A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Asimadoline on the Duration of POI in Subjects Undergoing Laparoscopic/Hand-Assisted Lap Segmental Colonic Resection Secondary to Colon Cancer, Polypectomy or Diverticulitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Time to Return of Upper and Lower GI Function
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of asimadoline in patients who have undergone a laparoscopic segmental colectomy and determine whether it reduces the time to recovery of bowel function compared to placebo.
详细描述
This randomized, double-blind, placebo-controlled study was designed to evaluate the efficacy and tolerability of two dose levels of asimadoline on the duration of post-operative ileus in subjects undergoing laparoscopic or hand-assisted laparoscopic colon resections. Subjects meeting entry criteria were randomized in a 1:1:1 ratio to receive either asimadoline 1.0 mg, asimadoline 3.0 mg or a placebo. One hundred and fourteen subjects were planned, and in the event that a subject was converted from a laparoscopic surgery to an open surgery (laparotomy), that subject would be discontinued from the trial and followed for safety only. The protocol allowed subjects converted to open procedures to be replaced. The first dose was administered approximately 90 minutes pre-operatively, and subsequent dosing was b.i.d. for up to 10 post-operative doses. Subjects were dosed with study drug only while in the hospital. After discharge, they were followed for an additional 28 days. Total study duration for each patient was approximately 5 to 6 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18-80
- •Must be scheduled to undergo a laparoscopic/hand-assisted laparoscopic segmental colectomy
- •Must sign an ICF
- •Females of childbearing potential must have a negative pregnancy test at screening
排除标准
- •Subjects with evidence of a biochemical or structural abnormality of the GI tract or other co-morbid illness that may impact the ability to interpret the safety and efficacy data
- •Pregnant or breastfeeding females
- •Use of investigational drugs in previous 30 days
- •Refusal to discontinue prohibited concomitant medications
- •Chronic use of prescription narcotics over the previous 6 months
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Asimadoline 1.0 mg
Asimadoline 1.0 mg b.i.d.
干预措施: Asimadoline (Drug)
Asimadoline 3.0 mg
Asimadoline 3.0 mg b.i.d.
干预措施: Asimadoline (Drug)
结局指标
主要结局
Time to Return of Upper and Lower GI Function
时间窗: Daily for 38 days
The time to first bowel movement or the time to tolerating solid food, whichever occurs later.
次要结局
- Time to Writing of Hospital Discharge Order(Daily for 38 days)
- Vomiting Score(Daily for 38 days)
- Nasogastric Tube Re-insertion(Daily for 38 days)
- Time to Tolerating Solid Food(4 hours of ingesting a meal)
- Adverse Events(Daily for 38 days)
- Time to First Bowel Movement(Daily for 38 days)
- Nausea Score(Daily for 38 days)
- Time to First Passage of Flatus(Daily for 38 days)
- Pain Score(Daily for 38 days)
- Post-operative Analgesic Use(Daily for 38 days)
- Laboratory Values(Daily for 38 days)