A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled Phase 2 Study of Once-Daily Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Laxation Response Within 2 Hours of the First Dose
研究概览
简要总结
The purpose of this study is to examine the safety and activity of MNTX in relieving opioid-induced constipation following orthopedic procedures.
详细描述
This is a double-blind, randomized, parallel-group, placebo- controlled Phase 2 study to evaluate the safety and activity of subcutaneous (SC) MNTX versus SC placebo in participants who have undergone orthopedic procedures and who are expected to require opioids for 1 week after randomization. Participants will sign an informed consent form and be screened between Days 4-10 after their orthopedic procedure. Those participants who meet all eligibility requirements will be enrolled in the study. Treatment with study medication will be continued until either the participant no longer requires opioid medication for pain relief or the maximum number of doses is reached. Originally, participants were receiving treatment for up to 7 days. Then after Protocol Amendment 1 (12 March 2008), the duration of treatment changed from "up to 7 days" to "up to 4 days".
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants greater than or equal to (>=) 18 years of age.
- •Participants must have undergone an orthopedic procedure (that is, total knee or hip replacement, spinal fusion, or reduction of fracture(s) with or without surgical fixation post trauma).
- •Participants must be receiving opioid analgesics (a mu agonist only-not to include agents with mixed mechanisms of action such as tramadol or buprenorphine) after the procedures and be expected to require daily opioid analgesics for at least 7 days post randomization.
- •Participants must be acutely constipated following their orthopedic procedure.
- •Participants must receive all doses of study drug in either hospitals or rehabilitation facilities.
- •Participants must sign an informed consent form.
- •Females of childbearing potential must have a negative pregnancy test and use appropriate birth control throughout the study.
- •Body weight within range of 40 kilograms (kg) - 150 kg (88 - 330 pounds [lbs]).
排除标准
- •Participants with known hypersensitivity to methylnaltrexone, naltrexone, or naloxone.
- •Participants who received any investigational new drug (experimental) in the previous 30 days.
- •Participants who have received a laxative (for example, lactulose) or an enema within 48 hours prior to the first dose.
- •Participants with constipation not attributed to post procedure opioids.
- •Participants with a history of alcohol or prescription or non-prescription drug abuse within the past 2 years.
- •Female participants who are pregnant or lactating.
- •Participants with a known history of chronic active hepatitis B or hepatitis C virus or human immunodeficiency virus (HIV) infection.
研究组 & 干预措施
MNTX
Participants will receive methylnaltrexone (MNTX) 12 milligrams (mg) subcutaneously (SC) once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.
干预措施: Methylnaltrexone bromide (Drug)
Placebo
Participants will receive placebo matching to MNTX SC once daily for up to 4 or 7 days, depending upon the protocol version under which each participant is enrolled.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants With Laxation Response Within 2 Hours of the First Dose
时间窗: 2 hours
Percentage of participants who had a laxation (that is, bowel movement) within 2 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
Percentage of Participants With Laxation Response Within 4 Hours of the First Dose
时间窗: 4 hours
Percentage of participants who had a laxation (that is, bowel movement) within 4 hours after the first dose of study drug, were reported. Participants taking stool softeners within 24 hours of study drug dosing and participants taking rescue laxative medications within 48 hours of study drug dosing were assessed as treatment failures.
次要结局
- Time to First Rescue-Free Bowel Movement (Laxation)(Baseline (Day 1) up to Day 4 or 7)