NCT02862977已完成3 期
Phase III, National, Multicenter, Randomized, Double-blind, Double-masked, Compare the Efficacy of Ketoprofen, Cyclobenzaprine and Caffeine Association Versus Cyclobenzaprine and Caffeine (Miosan Caf®) in the Treatment of Osteomuscular Pain in Adults
EMS6 个研究点 分布在 1 个国家目标入组 414 人开始时间: 2017年11月10日最近更新:
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
- 入组人数
- 414
- 试验地点
- 6
- 主要终点
- Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of an association with one anti-inflammatory and one muscle relaxant plus caffeine compared to one anti-inflammatory plus caffeine in the treatment of osteomuscular pain in adults.
详细描述
- Double-blind,randomized, multicenter
- Maximal experiment duration: 9 days
- 02 or 03 visits and a phone contact
- Evaluate the efficacy of an association with one anti-inflammatory and one muscle relaxant agent with caffeine compared to the one muscle relaxant agent plus caffeine in the treatment of osteomuscular pain in adults.
- Adverse events evaluation
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Consent of the patient;
- •Participants presenting musculoskeletal pain, moderate or moderately severe, with VAS (visual analog scale) greater than 40 mm for a period of less than seven (7) days.
排除标准
- •Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
- •Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Participation in clinical trial in the year prior to this study;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Patients who were in use of drugs that can interfere with evaluation;
- •History of with rheumatic diseases, fibromyalgia, osteoarticular diseases, dystonia, dystrophies and myopathies, acute infectious diseases, gastric duodenal ulcer or gastritis;
- •Renal or hepatic impairment.
研究组 & 干预措施
EMS association
Experimental
The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h.
干预措施: ketoprofen and cyclobenzaprine association with caffeine (Drug)
Miosan Caf®
Active Comparator
The patient will take 2 tablets (combination of Cyclobenzaprine and caffeine), oral, per day, each 12h.
干预措施: Cyclobenzaprine with caffeine (Drug)
结局指标
主要结局
Efficacy of osteomuscular treatment based on proportion of participants who achieve the 2, 3 or 4 points in the pain scale.
时间窗: 48 hours
次要结局
- Safety will be evaluated by the adverse events occurrences(Maximal experiment duration: 9 days)
研究者
研究点 (6)
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