NCT00298974已完成3 期
A Phase 3, Randomized, Multicenter, Double-blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 873
- 试验地点
- 83
- 主要终点
- Pain Intensity
研究概览
简要总结
The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.
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
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 21 to 80
- •If female, must be of non-child bearing potential or practicing birth control
- •Has osteoarthritis of the hip or knee
- •Requires therapeutic doses of medication for osteoarthritis pain
- •Has sufficient pain to justify the use of around-the-clock opioids
排除标准
- •Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
- •Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
- •Cannot discontinue pain medications, even for the short time prior to the study start
- •Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
- •Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
- •Has a history of malnutrition or starvation
- •Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
- •Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
- •Pregnant or breastfeeding females
- •Is incapacitated, bedridden or confined to a wheelchair
- •Has initiated any new therapy or medication for OA within 1 month of screening
- •Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
- •Has other conditions that may cause pain, such as rheumatoid arthritis or gout
研究组 & 干预措施
hydrocodone/acetaminophen extended release
Experimental
干预措施: hydrocodone / acetaminophen extended release (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity
时间窗: 12 weeks
Arthritis Pain Intensity measured by a 100mm Visual Analog Scale (VAS)
次要结局
- Pain intensity difference (PID) from baseline to each scheduled evaluation(12 weeks)
- Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score(12 weeks)
- SF-36v2 Health Status Survey(12 weeks)
研究者
研究点 (83)
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