A Phase 3, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Study of Intravenous (IV) Methylnaltrexone Bromide (MNTX) in the Treatment of Post-Operative Ileus (POI)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 524
- 试验地点
- 1
- 主要终点
- Time to First Bowel Movement
研究概览
简要总结
To evaluate the safety and efficacy of MNTX in participants who have undergone segmental colectomy and to assess if the time between the end of surgery and the first bowel movement is significantly shorter in the MNTX regimen than the equivalent assessment using a placebo regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants at least 18 years of age.
- •All participants must meet American Society of Anesthesiologists (ASA) physical status I, II, or III.
- •Participants must sign an informed consent form (ICF).
- •Participants must be scheduled for a segmental colectomy via open laparotomy with general anesthesia.
- •Females of childbearing potential must have a negative serum pregnancy test at the screening visit.
- •Negative for history of chronic active hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection.
排除标准
- •Participants who received any investigational new drug in the 30 days prior to screening visit.
- •Females who are pregnant or lactating.
研究组 & 干预措施
MNTX 12 mg
Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) as an intravenous (IV) infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
干预措施: Methylnaltrexone (Drug)
MNTX 24 mg
Participants will receive MNTX 24 mg as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
干预措施: Methylnaltrexone (Drug)
Placebo
Participants will receive placebo matching to MNTX as an IV infusion over approximately 20 minutes for every 6 hours until one of the following occurs: 1) 24 hours elapsed after the first bowel movement and the participant was tolerating clear liquids, 2) the participant was discharged from the hospital, or 3) a maximum of 10 days elapsed. The first dose of study drug will be administered within the first 90 minutes after the end of surgery (defined as the time when the last skin suture or staple is placed in the participant).
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Bowel Movement
时间窗: Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10
Time to first bowel movement was measured from the end of surgery (defined as the time when the last skin suture or staple was placed in the participant). Time of the first bowel movement was recorded on the electronic case report form (eCRF). The first bowel movement was defined as a normal stool for a postoperative participant based on the clinical judgment of the investigator or designee. Analysis was performed by Kaplan-Meier estimate. Participants who had a bowel movement but were readmitted to the hospital within 1 week after discharge with a diagnosis of postoperative ileus (POI) were considered censored at the time of the first bowel movement as if the bowel movement had not occurred.
次要结局
- Time to Discharge Eligibility(Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10)
- Time to Discharge Order Written From the End of Surgery(Day 1 (From the time of end of surgery [that is; from the first dose of study drug administration]) up to Day 10)
- Number of Participants With Clinically Meaningful Events (CMEs) for Nausea or Retching/Vomiting at 0 or 24 Hours as Evaluated by the Opioid-Related Symptom Distress Scale (SDS)(0 and 24 hours)