Study Evaluating the Efficacy and Safety of Subcutaneous Methylnaltrexone (MOA-728) for the Treatment of Opioid-Induced-Constipation
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, And Parallel-Group Study Of Subcutaneous Methylnaltrexone (MOA-728) For The Treatment Of Opioid-Induced Constipation In Adult Subjects
研究概览
详细说明
Subjects received subcutaneous methylnaltrexone (also referred to as MOA-728 or MNTX) or placebo every other day beginning on Day 1 up to a maximum of 7 doses during the 2-week double-blind period.
Inclusion criteria for this study included subjects with advanced illness or subjects with chronic nonmalignant pain. The actual study population included only subjects with cancer-related advanced illness.
All subjects who completed the double-blind treatment phase of this study could elect to receive methylnaltrexone during a 12-week open-label extension study, provided eligibility criteria were met. Subjects who did not continue in the open-label extension study had a follow-up visit 2 weeks after their last dose of test article.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women who are at least 18 years of age, and who have a diagnosis of advanced illness with anticipated life expectancy >= 1 month;
- Is receiving a regular dose of opioids for the control of pain;
- Has a diagnosis of opioid induced constipation;
- Is on a stable laxative regimen.
Exclusion Criteria:
- Has a known or suspected mechanical gastrointestinal obstruction, or any potential non-opioid cause of bowel dysfunction contributed to constipation;
- Has evidence of current fecal impaction;
- Has evidence of active diverticulitis, or peritonitis, or a history of bowel surgery within 30 days before test article administration;
- Has a body weight less than 27 kg
- Has any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of the study, or could preclude the evaluation of the subject's response.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Methylnaltrexone double-blind
Methylnaltrexone once every other day.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
其他名称：
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安慰剂比较：Placebo
Placebo once every other day.
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Subjects received matching placebo injections. Study duration: 2 weeks double-blind period (placebo treatments) followed by 12 weeks open-label extension period (MNTX treatments). |
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其他：Methylnaltrexone open-label
Subjects who completed the double-blind period had the option to receive methylnaltrexone once every other day during a 12-week, open-label extension period.
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Subjects received 0.6 mL (12 mg) every other day if weight ≥ 62kg; 0.4 mL (8 mg) every other day if weight between 38 and < 62 kg; or 0.0075 mL/kg (0.15 mg/kg) every other day if weight between 27 and <38 kg. Study duration: 2 weeks double-blind period (MNTX treatments) followed by 12 weeks open-label extension period (MNTX treatments).
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After the First Injection.
大体时间：Up to 4 hours after the first injection
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There were 2 co-primary endpoints for this study.
This measurement is the first of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after the first dose of test article during the double-blind period; data are expressed as percentages of patients for the MNTX and placebo groups.
To qualify as rescue free, the bowel movement could not occur within 6 hours after a rectal intervention (ie, rectal suppository, enema, manual disimpaction).
Note that efficacy results (primary and secondary outcomes) are presented for the double-blind period only.
Therefore, no efficacy results are presented for the open-label period.
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Up to 4 hours after the first injection
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The Proportion of Subjects Having a Rescue-free Bowel Movement (RFBM) Within 4 Hours After Each Dose During Double-blind Period.
大体时间：Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This measurement is the second of the 2 co-primary endpoints.
This endpoint measures the percentage of patients who had an RFBM within 4 hours after each dose of test article during the double-blind period; data are expressed as percentages of patients by dose (first, second, third, fourth, etc.) for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Injections Resulting in RFBM Within 4 Hours After Test Article Administration.
大体时间：Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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This endpoint measures the percentage of injections resulting in RFBMs within 4 hours after test article administration during the double-blind period.
The percentage of injections resulting in RFBMs is calculated for each patient and then data are expressed as the mean (± standard deviation) percentage for the MNTX and placebo groups.
The definition of RFBM is described above (see first co-primary endpoint).
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Within 4 Hours After Each Dose During the 2 weeks Double-Blind Period
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合作者和调查者
调查人员
- 研究主任：Enoch Bortey、Bausch Health Americas, Inc.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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