NCT00949377撤回4 期
Can Methylnaltrexone Safely Treat Opioid Related Constipation in the Emergency Department?
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Laxation
研究概览
简要总结
The investigators want to prove that people WITHOUT advanced cancer who are taking opioid medications (for problems like back pain) can receive methylnaltrexone (MNTX) safely. Since the FDA has only approved MNTX for advanced cancer patients, the investigators' research is investigating how MNTX can work for NON-cancer patients. This research is being conducted to prove that MNTX can work for non-cancer patients with opioid related constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Pregnancy or lactation
- •Recent surgery within six (6) weeks of the emergency department visit
- •Opioid withdrawal syndrome as determined by clinical judgment.
- •Patients with previous history of diabetic gastroparesis.
- •Any patient who has known or suspected gastrointestinal obstruction
- •Any patients with creatinine clearance ≤ 30 mL/min
- •Constipation for which other medical causes cannot be excluded such as anticholinergic medications, botulinum toxin, or botulism.
- •Any patient with SBP ≤ 80 mmHg or DBP ≤ 45 mmHg or unstable vital signs.
- •Inability to understand or follow the instructions associated with the clinical study as determined by clinical judgment.
- •A known history of substance abuse on methadone maintenance therapy > 12 months
- •Allergy or contraindication to use of methylnaltrexone
- •Prior enrollment in study
研究组 & 干预措施
Methylnaltrexone Bromide
Experimental
干预措施: Methylnaltrexone Bromide (MNTX) (Drug)
Normal Saline
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Laxation
时间窗: 4 hours
次要结局
- Opioid withdrawal symptoms(36 hours)
研究者
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