Methylnaltrexone Versus Naloxegol in the Treatment of Opioid-Induced Constipation in the Emergency Department
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Occurrence of Bowl Movement
研究概览
简要总结
The purpose of this study is to compare the efficacy of subcutaneous versus oral mu-opioid receptor antagonist therapy in opioid induced constipation that is refractory to other bowel regimens.
详细描述
Opioid-induced constipation can lead to serious complications, including small bowel obstruction, fecal impaction, and bowel perforation. Not only are the medical complications potentially severe, patient quality of life can also be impacted. Two agents are currently available for opioid-induced constipation - oral and subcutaneous methylnaltrexone and oral naloxegol. Mechanistically, both agents antagonize the peripheral mu-opioid receptor in the gastrointestinal tract to decrease constipation without reversing the systemic analgesic effects of opiates. The literature currently available has evaluated the effectiveness of each agent, not the comparative effectiveness of these agents.
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)
盲法说明
Each participant will be receiving one injection and tablets which have been randomly assigned.
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
- •Complaint of opioid-induced constipation refractory to other therapy (enemas, laxatives, stool softeners)
- •Age≥18y/o
- •Not pregnant or lactating (negative urinary pregnancy test)
- •No contraindication to Methylnaltrexone or Naloxegol
排除标准
- •Age<18y/o
- •Pregnancy or lactation
- •Contraindication to Methylnaltrexone or Naloxegol
- •Assigned NPO
- •Small bowel obstruction
研究组 & 干预措施
Methylnaltrexone oral tablets
Methylnaltrexone oral tablets (total 450 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
干预措施: Methylnaltrexone Bromide 150 mg Oral Tablet (Drug)
Methylnaltrexone subcutaneous injection
Methylnaltrexone 12mg subcutaneous injection + sugar placebo tablet
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
干预措施: Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1 (Drug)
Naloxegol oral tablets
Naloxegol oral tablets (total 25 mg) + subcutaneous water injection
Eligible patients with complaint of opioid-induced constipation will receive this treatment after study enrollment. Time to bowel movement will be recorded until 3 hours in the emergency department, and patient will be contacted after 24 hours if bowel movement was not achieved after the 3 hours.
干预措施: Naloxegol 25 MG Oral Tablet (Drug)
结局指标
主要结局
Occurrence of Bowl Movement
时间窗: 24 hours
The primary outcome of this study is to determine the effectiveness of peripherally acting mu-opioid receptor antagonist therapy for patients presenting to the emergency department (ED) with opioid-induced constipation.
次要结局
- Time to Bowl Movement Within 24 Hours(24 hours after administration of study drug)
研究者
Kara B. Goddard, PharmD, BCPS
Clinical Pharmacy Specialist
University of Missouri-Columbia