Non Inferiority,Phase III,Multicentric,Double Blind,Randomized,Parallel Study,Comparing Dolamin Flex (Lysine Clonixinate+Cyclobenzaprine) and Tandrilax(Caffeine +Carisoprodol+Diclofenac+Paracetamol)in Pain Reduction in Patients With Lumbago
试验速览
- 阶段
- 3 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain average reduction
研究概览
简要总结
Non inferiority, multicentric, double blind study whose the primary objective is to compare the effectiveness of two products in pain reduction. Primary endpoint: reduction in pain average at day 7 compared to day 1(baseline), using Analogue Visual Scale (AVS) for pain evaluation. Secondary endpoint: to evaluate the products safety at the gastrointestinal system.
详细描述
Phase IIIb, non-inferiority, multicentric, double-blind study.Population: 160 patients, 80 in each study arm, both gender with mild to moderate lumbago, without irradiation and with muscle contraction, aged 18 (eighteen) and 65 (sixty five) years, without previous history of stomach or duodenal ulcer and gastritis.
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
- •Informed of the nature of the study and given written informed consent
- •Patients with mild to moderate lumbago
- •Aged between 18 and 65 years old
排除标准
- •Known allergy or sensitivity to drug components
- •Treatment with another anti inflammatory or corticoid
- •Treatment with oral anticoagulants
- •Treatment with oxidase monoamine 2 weeks before the study
- •Treatment with methotrexate
- •Stomach or duodenal ulcer and gastritis
- •Dehydration
- •Acute myocardial infarction or heart failure
- •Hyperthyroidism
- •Pregnant or lactating patients
- •Treatment with lithium
- •User of alcohol and barbiturates
- •Hepatic or renal failure
研究组 & 干预措施
Tandrilax
Reference product Intervention: Drug: Tandrilax (caffeine+carisoprodol+sodium diclofenac+paracetamol)
干预措施: Tandrilax (Drug)
Dolamin Flex
Test product Intervention: Drug: Dolamin Flex (Lysine clonixinate and cyclobenzaprine)
干预措施: Dolamin Flex (Drug)
结局指标
主要结局
Pain average reduction
时间窗: 7 days
The metric that will be used is Pain Analog Visual Scale (PAVS), that it is a graphical representation with values 0-10. To use the PAVS, the principal investigator should question the patient regarding their pain level, and the value 0 (zero) means no pain and the value 10 (ten) indicates the maximum pain level.
次要结局
- Identification of possible gastrointestinal effects(7 days)