A Phase III, Randomized, Multicenter, Open Label Clinical Trial: Efficacy and Safety of the Injectable Association of Dexamethasone, Dipyrone, and Hydrocobalamin in Lumbar Sciatic Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- efficacy
研究概览
简要总结
A phase III, randomized, multicenter, open label clinical trial to evaluate efficacy and safety of the injectable association of dexamethasone, dipyrone, and hydroxocobalamin in lumbar sciatic pain. The study will enroll 140 patients in each arm (280 total).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sign the study informed consent form;
- •To be diagnosed with moderate to severe lumbar sciatic pain (defined as limiting the work activities or the ordinary tasks performance or at the investigator's discretion) within the last 3 days;
- •Aged 18 to 75 years old;
- •To be able to meet the study procedures
排除标准
- •o-Diagnosed with chronic rheumatologic diseases, except recurrent lumbar sciatic pain;
- •Patients with one of the following conditions, as per the investigator's criteria:
- •Severe renal failure under hemodialysis, severe liver failure, uncontrolled severe heart failure;
- •Severe injuries on gastrointestinal tract;
- •Other severe comorbidities;
- •Patients taking acetylsalicylic acid or any anti-clotting;
- •Female patients who are pregnant, lactating, willing to get pregnant or not willing to use an appropriate contraceptive method during the study period.
研究组 & 干预措施
dexalgen
Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose for 3 days, at least
干预措施: Dextralgen (Drug)
Meloxicam
Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose for at least 3 days.
干预措施: Meloxicam (Drug)
结局指标
主要结局
efficacy
时间窗: 6 months
The efficacy analysis will be at the per protocol population, with the VAS measure after three treatment dosages. The VAS scale consists on a straight line of 100 mm in which the patient marks, at any point through the straight line, the point he/she considers to describe the pain level he/she feels. After the patient marks the straight line, classifying his/her pain, it is measured with a millimeter-graded standard rule, the distance between the mark and the extremity "No pain" at the scale.
次要结局
未报告次要终点