NCT00404183已完成2 期
A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 120
- 主要终点
- Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen with placebo over a 5-week dosing period in patients with osteoarthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ages 21 to 75
- •Has osteoarthritis of the hip or knee
- •Requires therapeutic doses of medications for osteoarthritis
- •If female, must be of non-childbearing potential or practicing birth control
- •Has sufficient pain to justify the use of round-the-clock opioids
排除标准
- •Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
- •Has certain medical conditions which may interfere with pain assessments
- •Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
- •Has had certain infections, injuries or illnesses within the last month
- •Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
- •Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
- •Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
- •Cannot discontinue pain medications, even for a short time, prior to the study start
研究组 & 干预措施
hydrocodone/acetaminophen extended release
Experimental
干预措施: Extended-Release Hydrocodone/Acetaminophen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
时间窗: 4 weeks
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
次要结局
- WOMAC Osteoarthritis Index, SF36(4 weeks)
研究者
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