A Multi-Center, Primary Care-Based, Open-Label Study to Assess the Success of Converting Opioid-Experienced Patients, With Chronic, Moderate to Severe Pain, to EMBEDA Using a Standardized Conversion Guide, and to Identify Behaviors Related to Prescription Opioid Abuse, Misuse, and Diversion
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 684
- 试验地点
- 159
- 主要终点
- Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
研究概览
简要总结
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
详细描述
The decision to terminate the trial was based on a lack of study drug supply. The decision was not based on any safety concerns. The termination letter was sent on 11March2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to read, speak and understand English
- •Have chronic moderate to severe pain for at least 3 months
- •Require around the clock opioid medication for the relief of pain
- •Have been taking a daily opioid for at least 30 days prior to starting the study
- •Be able to be safely switched to a different pain medication
- •Be practicing acceptable birth control methods for female patients of childbearing potential
- •Be willing to participate in the study and able to comply with study procedures
排除标准
- •Be currently diagnosed with or participating in and/or seeking treatment for opioid and/or alcohol abuse
- •Be allergic or intolerant to morphine, morphine salts, naltrexone or other opioids
- •Be currently taking tramadol and/or extended release morphine products
- •Have respiratory depression
- •Have acute or severe bronchial asthma or severe chronic obstructive pulmonary disease
- •Have migraines as your main source of pain
- •Have any form of bowel obstruction
- •Be pregnant or breast feeding
- •Have had 2 or more surgeries for low back pain
- •Be planning a major surgery during the study
- •Be staying in a hospital or nursing home
- •Be planning to have steroid injections for your chronic pain during the study
- •Have a life expectancy of less than 2 months
研究组 & 干预措施
morphine sulfate and naltrexone hydrochloride (EMBEDA)
干预措施: morphine sulfate and naltrexone hydrochloride (EMBEDA) (Drug)
结局指标
主要结局
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase
时间窗: Baseline through Week 6
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Percentage of Participants Achieving Stable Dose of EMBEDA Within 6 Weeks Titration Phase Stratified by Prior Opioid Therapy
时间窗: Baseline through Week 6
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
次要结局
- Investigator's Level of Satisfaction With the EMBEDA Conversion Guide(Week 6)
- Change From Baseline in Brief Pain Inventory (BPI) at Visit 3 (First Visit After Successful Titration)(Baseline, Visit 3 (up to Week 6))
- Number of Titration Steps to Achieve Stable Dose(Baseline through Week 6)
- Number of Titration Steps to Achieve Stable Dose Stratified by Prior Opioid Therapy(Baseline through Week 6)
- Percentage of Participants With Rescue Medications Usage During Titration(Baseline through Week 6)
- Duration to Titrate Participants to Stable Dose Stratified by Prior Opioid Therapy(Baseline through Week 6)
- Duration to Titrate Participants to Stable Dose(Baseline through Week 6)