A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Efficacy Study of Kadian NT (Morphine Sulfate Plus Naltrexone Hydrochloride Extended-Release) Capsules in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 547
- 试验地点
- 79
- 主要终点
- Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with placebo for treating moderate to severe chronic pain over a 12 week period.
详细描述
The primary objective of this study is to evaluate the efficacy of ALO-01 compared with placebo for the treatment of chronic moderate to severe pain (focusing on osteoarthritis of the hip or knee) as measured by mean change in diary Brief Pain Inventory (BPI) score of average pain (daily scores of average pain averaged over 7 days) from randomization to 12 weeks following randomization.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 21 years of age or older
- •Subject is either not of childbearing potential OR subject must use an acceptable method of birth control if of childbearing potential
- •Negative pregnancy test if female of childbearing potential
- •Subject is in general good health
- •Subject required treatment of joint pain within the last 90 days
- •Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee
排除标准
- •Subject has a documented history of allergic reaction or intolerance to morphine or other opioids
- •Subject is pregnant or breast-feeding
- •Subject is receiving systemic chemotherapy
- •Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence
- •Subject has history of major depressive disorder not controlled with medication
- •Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the symptoms of OA
- •Subject has active gastrointestinal disease, with the exception of gastroesophageal reflux disease (GERD)
- •Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory arthritis
研究组 & 干预措施
ALO-01
Up to 80 mg twice a day (bid)
干预措施: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release) (Drug)
Placebo
Twice a day (bid)
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Randomization to 12 Weeks Following Randomization in Diary Brief Pain Inventory Score of Average Pain (Daily Scores of Average Pain Averaged Over 7 Days)
时间窗: randomization to 12 weeks following randomization
Change in pain intensity scale. Average pain intensity over last 24 hours rated daily from 0=no pain to 10=worst pain.
次要结局
未报告次要终点