NCT01367561已完成1 期
A Phase I Urodynamic Study of the Opioid Antagonist, Naloxone and Intravenous Methylnaltrexone Reverse Opioid Effects on Bladder Function in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Maximal force of detrusor contraction (Pdet) after administration of MNTX
研究概览
简要总结
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males, 18 to 65 yrs with normal urinary function
- •Body weight less than 150 kg and Body Mass Index between 20-32.
排除标准
- •History of drug or alcohol abuse
- •History of significant chronic illness (cardiovascular, gastrointestinal, pulmonary, neurologic, endocrine, renal, hepatic, etc.)
- •Subjects who received opioids for one week or longer in the last 2 months.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Naloxone (Drug)
Arm 2
Experimental
干预措施: IV Methylnaltrexone (MNTX) (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Maximal force of detrusor contraction (Pdet) after administration of MNTX
时间窗: 14 days
To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.
次要结局
未报告次要终点
研究者
研究点 (1)
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