NCT03768466已完成4 期
An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 4
- 主要终点
- Change of NRS average score from week 0 to week 8
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Korean patients age ≥ 19 years old
- •Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs
- •Patients showing average NRS pain score ≥4 over the last 1 week at screening point
- •In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment
- •Patients who is willing to voluntarily sign informed consent
排除标准
- •Patients with any history of hypersensitivity to oxycodone, naloxone or related products
- •Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause
- •Pregnant or lactating women
结局指标
主要结局
Change of NRS average score from week 0 to week 8
时间窗: week 8
reduction of pain intensity of week 8 average NRS score
次要结局
未报告次要终点
研究者
研究点 (4)
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