NCT01028079已完成3 期
Placebo and Active Controlled, Double Dummy Phase III Study to Prove Efficacy of Aspirin (1000 mg Solid Dose) in Treatment of Acute 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
- Bayer
- 入组人数
- 338
- 主要终点
- Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (the study medication) by comparing it to placebo (the control group without active substance) or 400 mg Ibuprofen (the control group with an active substance) in treating the symptoms of back pain. The study is designed to develop a treatment method against back pain which will have more advantages for patients than the methods that are currently available.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory male or female, 18 to 70 years of age
- •Body mass index ranging in-between 18 and 30 kg/m²
- •Normal blood pressure
- •Patients suffering from low back pain
- •Low back pain, localized below the costal margin and above the inferior gluteal folds, either as acute low back pain, or as chronic or intermittent low back pain
排除标准
- •Hypersensitivity to acetylsalicylic, salicylates, or other Non Steroidal Anti-inflammatory drugs
- •Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
- •Pregnancy or lactation period
- •Abuse of alcohol or addictive substances
研究组 & 干预措施
Arm 2
Active Comparator
干预措施: Ibuprofen (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Acetylsalicylic Acid (Aspirin, BAYE4465) (Drug)
结局指标
主要结局
Area under the curve of the baseline adjusted pain intensity curve over the initial 48 hours (AUC-PI0-48hours) after first dosing
时间窗: 48 hours
次要结局
- Pain intensity difference after 48, 72, 96 and 120 hours after first dosing(48, 72, 96 and 120 hours)
- Total pain relief 6, 72, 96 and 120 hours after first dosing(6, 72, 96 and 120 hours)
- Pain intensity relief over initial 6 hours(6 hours)
- Overall efficacy after 48, 72, 96 and 120 hours after first dosing(48, 72, 96 and 120 hours)
- Total dose used over 5 days(5 days)
- Time till use of rescue medication(5 days)
- Safety - assessment of adverse events(5 days)
研究者
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