NCT00858754撤回4 期
A Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Subcutaneous Methylnaltrexone for the Treatment of Opioid-Induced Constipation in Subjects With Cancer-Related Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
研究概览
简要总结
This purpose of this study is to evaluate the safety and effectiveness of a subcutaneous (injection beneath the skin) form of methylnaltrexone in subjects who have cancer-related pain and constipation from taking opioids. The length of participation will be up to 7 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a man or woman aged 18 years or older.
- •Has a body weight >= 38 kg.
- •Has cancer (active or in remission), and has cancer-related pain (ie, pain due to cancer or treatment of cancer).
- •Has a life expectancy of >= 6 months.
- •Has a performance status of 0, 1, or 2 based on the Eastern Cooperative Oncology Group (ECOG) scale.
- •Is taking opioids for cancer-related pain, and not just as-needed doses.
- •Has a diagnosis of OIC as determined by the investigator.
- •Is willing to follow the protocol instructions on laxative use during the study.
排除标准
- •Has a history of chronic constipation before starting opioids.
- •Has renal disease receiving dialysis.
- •Has an ostomy for stools.
- •Is a pregnant or breastfeeding woman.
研究组 & 干预措施
Group 1 Active Drug
Experimental
Methylnaltrexone
干预措施: methylnaltrexone (Drug)
Group 2 Non-Active Drug
Placebo Comparator
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Bowel movement within 4 hours after the first dose. Collection of adverse events, vital signs measurements, and laboratory assessments.
时间窗: 1 Day
次要结局
- 1. Bowel movements within 4 hours after at least 2 of the first 4 doses. 2. Bowel movements within 4 hours after all doses. 3. The time to bowel movement after the first dose.(2 weeks)
研究者
研究点 (1)
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