A Randomized, Double-blind, Active Controlled, Parallel, Multicenter, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of NVP-1203 in Patients With Acute Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety NVP-1203 in patients with acute low back pain.
详细描述
This study is a randomized, double-blind, active-controlled, parallel, phase 3 study to evaluate efficacy and safety of NVP-1203 in patients with acute low back pain.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing
- •Subjects who have symptom of acute low back pain
排除标准
- •Subjects who cannot prohibit anti-inflammatory drug or muscle relaxants during clinical trial
- •Inadequate subject for the clinical trial by the investigator's decision
研究组 & 干预措施
NVP-1203
NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
干预措施: NVP-1203 (Drug)
NVP-1203
NVP-1203 plus NVP-1203-R placebo for up to 7 days, oral dose
干预措施: NVP-1203-R placebo (Drug)
NVP-1203-R
NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
干预措施: NVP-1203-R (Drug)
NVP-1203-R
NVP-1203-R plus NVP-1203 placebo for up to 7 days, oral dose
干预措施: NVP-1203 placebo (Drug)
结局指标
主要结局
Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)
时间窗: Baseline and Day 7
Pain intensity is assessed by 100 mm Visual Analogue Scale(VAS) (0 mm = no pain and 100 mm = maximum pain) evaluated from baseline to Day 7.
次要结局
- Change from baseline in Oswestry Disability Index(ODI)(Baseline, Day 3 and Day 7)
- Change from baseline in pain intensity assessed by Visual Analogue Scale(VAS)(Baseline and Day 3)
- Change from baseline in Finger to Floor Distance(FFD)(Baseline, Day 3 and Day 7)
- Change from baseline in Physician's Global Assessment of Response to Therapy(PGART)(Baseline and Day 7)