Open-label, Single-group, Multicentre, Phase III Study to Confirm the Efficacy and Safety of IP-TN When Administered for 2 Weeks to Patients With Low Back Pain, Scapulohumeral Periarthritis, or Cervico-omo-brachial Syndrome Associated With Muscle Strain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Percentage of Patients With Drug-related Adverse Events [AEs]
研究概览
简要总结
This is an open-label, single-group, multi-centre trial to confirm the safety and efficacy of loxoprofen sodium/methocarbamol ( IP-TN) when administered orally for 2 weeks to patients with low back pain, scapulohumeral periarthritis, or cervico-omo-brachial syndrome associated with muscle strain. More than 90 patients will be screened to enroll approximately 80 patients in the trial.
After giving written informed consent, patients will be enrolled in the trial. Patients who are considered eligible for the trial by the Investigator after consent and complete the trial procedures and assessments at Visit 1 will receive the trial medication and enter the open-label treatment period of 2 weeks. Patients who complete the open-label treatment period will enter the follow-up period of 1 week and complete the trial after confirmation at the last visit (or phone interview).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Loxoprofen sodium/methocarbamol FDC
fixed dose combination (FDC) tablets
干预措施: Loxoprofen sodium (Drug)
Loxoprofen sodium/methocarbamol FDC
fixed dose combination (FDC) tablets
干预措施: Methocarbamol (Drug)
结局指标
主要结局
Percentage of Patients With Drug-related Adverse Events [AEs]
时间窗: Up to 3 weeks.
The outcome measure presents percentage of patients with drug-related AEs.
次要结局
- Assessment of Pain Due to Low Back Pain, Scapulohumeral Periarthritis or Cervico-omo-brachial Syndrome After 2 Weeks of Treatment(Post 2 weeks.)
