NCT00325949已完成3 期
A Phase 3, Open-Label Period Followed By a Randomized, Double-Blind, Placebo-Controlled Study of the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) Compared to Placebo in Subjects With Chronic Low Back Pain
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
- 770
- 试验地点
- 63
- 主要终点
- Pain Intensity Difference from randomization baseline to each subject's final assessment
研究概览
简要总结
This is a study of the safety and pain-relieving ability of extended release hydrocodone and acetaminophen tablets in patients with moderate to severe low back pain
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 21-75 years
- •If female, must be of non-child bearing potential or practicing birth control
- •Has a history of chronic low back pain for at least 6 months
- •Requires medication for the management of the chronic low back 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 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, or plans to have surgery
- •Has a history of gastric bypass surgery or preexisting 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
- •Is a pregnant or breastfeeding woman
- •Is incapacitated, bedridden, or confined to a wheelchair
- •Has initiated any new therapy or medication for chronic low back pain within 1 month of screening
- •Has had surgery, certain types of low back procedures, injured, or received certain medications for chronic low back pain within a certain specified time frame
- •Has back pain due to or associated with certain types of conditions
- •Has other conditions that may cause pain, such as rheumatoid arthritis, gout, or fibromyalgia
研究组 & 干预措施
arm label (2) hydrocodone/acetaminophen extended release
Experimental
干预措施: hydrocodone/acetaminophen extended release (Vicodin CR) (Drug)
Arm label (3) placebo
Placebo Comparator
干预措施: placebo (Drug)
arm label (1) hydrocodone/acetaminophen extended release
Experimental
干预措施: Extended release hydrocodone and acetaminophen (Vicodin CR) (Drug)
结局指标
主要结局
Pain Intensity Difference from randomization baseline to each subject's final assessment
时间窗: 12 Weeks
Pain intensity difference assessed by the Chronic Low Back Pain Intensity Score (100mm Visual Analog Scale)
次要结局
- Time to withdrawal due to lack of efficacy during the Double-blind Maintenance Period
- Pain Intensity Difference from randomization baseline to each scheduled assessment
- Global Assessments of Study Drug and Back Pain Status
- Roland-Morris Disability Questionnaire
研究者
研究点 (63)
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