NCT00643383已完成3 期
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the 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
- 入组人数
- 277
- 主要终点
- Pain Intensity change from Baseline
研究概览
简要总结
A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females in generally good health aged 18-80 years with moderate to severe acute low back pain.
- •Current acute low back pain episode within 48h prior to study entry.
- •Pain must be moderate to severe following incident
排除标准
- •Chronic low back pain
- •Ongoing or history of alcohol or drug abuse
- •Body Mass Index greater 39
- •Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors
- •Known history or symptoms suspicious for cancer
- •Significant renal or liver disease
- •Spinal surgery within 1 year of study entry.
- •Subjects who are pregnant or lactating.
- •Subjects with unstable medical disease.
- •Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.
研究组 & 干预措施
1
Active Comparator
干预措施: Combination drug (Acetaminophen + Tramadol) (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Intensity change from Baseline
次要结局
- Overall satisfaction with the study medication
- Safety evaluation
研究者
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