A Compassionate Use Study of Methylnaltrexone in Patients With Opioid-Induced Side Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Number of Participants With Opioid Induced Side Effects
研究概览
简要总结
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced medical illness (that is; terminal illness, such as incurable cancer or end stage aqcuired immunodeficiency syndrome [AIDS]) with a life expectancy of one to six months.
- •On an opioid regimen for the control of pain/discomfort for at least seven days.
- •Has opioid-induced constipation.
- •Stable vital signs and systolic blood pressure greater than or equal to (>=) 85 millimeters of mercury (mmHg), and diastolic blood pressure >=45 mmHg (Supine or sitting).
- •Females of childbearing potential must have a negative pregnancy test (serum or urine).
- •On a laxative regimen (for example, stool softener and SENNA or equivalent) for at least 3 days prior to treatment. Participants who have discontinued laxatives due to intolerability or lack of efficacy are also eligible.
排除标准
- •Participants with known hypersensitivity to methylnaltrexone, naltrexone or naloxone.
- •Participants who received any investigational new drug (experimental) except for methylnaltrexone in the previous 30 days.
- •Participants who are constipated with a disease process suggestive of gastrointestinal obstruction, impaction or diagnosed with a current abdominal pathologic process which may represent a non-opioid cause of bowel dysfunction.
- •Participants who are constipated and have active, clinically significant diverticulitis.
- •Participants with a surgically acute abdomen.
- •Participants being treated with opioids for diarrhea, dyspnea, cough, pulmonary edema, or congestive heart failure.
- •Individuals with a known drug addiction.
- •Females who are pregnant or nursing.
研究组 & 干预措施
Methylnaltrexone
Participants will receive single dose of MNTX 0.15 milligrams per kilogram (mg/kg) subcutaneously (SC). Subsequent dosing could be adjusted upward (to a maximum of 0.3 mg/kg) to achieve a desired clinical response or decreased to improve tolerability.
干预措施: Methylnaltrexone (Drug)
结局指标
主要结局
Number of Participants With Opioid Induced Side Effects
时间窗: From start of treatment until end of study (up to maximum 3.4 years)
Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
次要结局
未报告次要终点