A Phase III, Randomized, Single-Blind, Superiority Study Comparing The Efficacy And Tolerability Of A New Drug Containing The Combination Meloxicam And Cyclobenzaprine And The Same Components Alone In The Treatment Of Acute Lumbago
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 11
- 主要终点
- Pain Reduction
研究概览
简要总结
The purpose of this study is to assess the efficacy end tolerability of a new drug containing the combination meloxicam and cyclobenzaprine (7,5/10mg) and the same components alone in the treatment of acute lumbago.
详细描述
To assess the efficacy and tolerability of a new drug containing the combination meloxicam and cyclobenzaprine in the treatment of acute lumbago, compared to the same components alone.
Some eligibility criteria:
Have a normal X-ray of the lumbar spine for the age; Have a baseline score in the VAS higher than or equal to 40 mm
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
- Single (Investigator)
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, initial and date the Informed Consent Form (ICF);
- •Be between 18 and 75 years old;
- •Have acute lumbago with onset in less than 72 hours;
- •Have a normal X-ray;
- •Have a baseline score in the VAS higher than or equal to 40 mm;
排除标准
- •Use of triptans;
- •Use of monoamine oxidase inhibitors;
- •Use of NSAIDs within the last week;
- •Previous use of narcotics;
- •Have any rheumatologic disease;
- •Conditions of chronic pain;
- •Have any significant chronic comorbidity;
- •Previous history of gastrointestinal bleed or ulcers;
- •History of allergy to any of the components of study medications;
- •Recent history of a myocardial infarction, cardiac arrhythmia, cardiac conduction block or change, or congestive heart failure;
- •Female patients who are pregnant or breastfeeding or who wish to become pregnant or who deny using safe contraceptive methods during the study will not be enrolled in the study;
- •Have participated in another clinical trial within the last 12 months.
研究组 & 干预措施
meloxicam - Movatec®
干预措施: meloxicam - Movatec® (Drug)
cyclobenzaprine - Miosan®,
干预措施: cyclobenzaprine - Miosan® (Drug)
meloxicam/cyclobenzaprine hydrochloride
干预措施: meloxicam/cyclobenzaprine hydrochloride (Drug)
结局指标
主要结局
Pain Reduction
时间窗: Pain reduction 3 days after the administration of study drugs
Compare the treatment groups for the efficacy in pain reduction, 3 days after the administration of study drugs, when compared to the baseline assessment.
次要结局
- Frequency of rescue medication use(During study treatment, an expected average of 7days)