A Randomized, Double-Blind, Placebo-Controlled Study Of A Fixed Dose Of Subcutaneous Methylnaltrexone In Adults With Advanced Illness And Opioid-Induced Constipation: Efficacy, Safety, And Additional Health Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
研究概览
简要总结
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
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 (Participant, Investigator)
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
- •Is an adult 18 years of age or older
- •Has a diagnosis of advanced illness (ie, a terminal illness such as incurable cancer or other end-stage disease)
- •Has a life expectancy of at least 1 month.
- •Is receiving opioids on a regular schedule (not just as-needed or rescue doses) for the control of pain or discomfort for at least 2 weeks before the first dose of study drug.
- •Has constipation that is caused by opioid medications.
排除标准
- •Has a known or suspected allergy to methylnaltrexone or other similar compounds (e.g. naltrexone or naloxone).
- •Has a known or suspected mechanical gastrointestinal obstruction.
- •Has any potential nonopioid cause of bowel dysfunction that might be a major contributor to the constipation.
- •Has any other clinically important abnormalities as determined by the investigator that may interfere with his or her participation in or compliance with the study.
- •Receiving opioid antagonist or partial antagonist products.
研究组 & 干预措施
Methylnaltrexone
Methylnaltrexone subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; or 0.4 mL (8 mg) every other day if weight between 38 and <62 kg. Subjects with impaired kidney function received reduced doses according to instructions in the Relistor prescribing information.
干预措施: Methylnaltrexone (Drug)
Placebo
Placebo subcutaneously every other day for 14 days (ie, 7 doses). Subjects received 0.6 mL every other day if weight ≥ 62kg; or 0.4 mL every other day if weight between 38 and < 62 kg. Subjects with impaired kidney function received reduced volumes of placebo solution to match the volumes used in the experimental group.
干预措施: Placebo (Drug)
结局指标
主要结局
The Proportion of Subjects Who Have a Rescue-free Laxation Response Within 4 Hours After at Least 2 of the First 4 Doses
时间窗: 7 days
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
次要结局
- Time to First Rescue-free Laxation (Following the First Dose of Study Drug).(14 days)