NCT02985216已完成3 期
A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy Between YHD1119 and Pregabalin in Patients With Peripheral Neuropathic Pain
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 371 人开始时间: 2017年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 371
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
研究概览
简要总结
A Randomized, Double-blind, Active-Controlled, Multi-center, Phase 3 Trial to Compare the Safety and Efficacy between YHD1119 and Pregabalin in Patients with Peripheral Neuropathic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Informed Consent
- •HbA1c ≤ 9.5% diabetes mellitus patients with pain over 6 months in Diabetic Peripheral Neuropathy or postherpetic Neuralgia patients at least 3 months pain after diagnosis of skin rash due to herpes zooster
排除标准
- •Have Brittle diabetes mellitus
研究组 & 干预措施
YHD1119
Experimental
YHD1119 150mg for the first 1 week, then forced titrated to YHD1119 300mg for the 1 week. And then YHD1119 150~600mg for the 2 weeks, then YHD1119 fixed dose was administrated for 8 weeks.
干预措施: YHD1119 (Drug)
Lyrica
Active Comparator
Lyrica 150mg for the first 1 week, then forced titrated to Lyrica 300mg for the 1 week. And then Lyrica 150~600mg for the 2 weeks, then Lyrica fixed dose was administrated for 8 weeks.
干预措施: Lyrica (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
时间窗: Baseline, Day 85
次要结局
- Clinical Global Impression of Change (CGIC)(Day 85)
- Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)(Day 1, 8, 15, 22, 29, 57, 85)
- Patients proportion of reduction over 30% in Mean Pain Score from Baseline(Day 1, 8, 15, 22, 29, 57, 85)
- Change of duration-modification from baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)(Day 1, 8, 15, 22, 29, 57, 85)
- Patient Global Impression of Change (PGIC)(Day 85)
- Mean Pain Score on the Daily Pain Rating Scale at each visit(Day 1, 8, 15, 22, 29, 57, 85)
- SF-12 (Short form-12)(Baseline, Day 85)
- C-SSRS (Columbia Suicide Severity Rating Scale)(Baseline, Day 8, 29, 85)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Clinical Trial of Temisartan/Amlodipine & Rosuvastatin in Subjects With Hypertension and HyperlipidemiaHypertensionHyperlipidemiaNCT03067688Yuhan Corporation202
已完成
3 期
Efficacy and Safety of CKDB-501A in Subjects With Moderate-to-severe Glabellar Lines in Phase 3 TrialGlabellar LinesNCT05804656CKD Bio Corporation300
已完成
3 期
Metformin/Atorvastatin Combination Therapy in Subjects With Type II Diabetes and Dyslipidemia (Phase 3)Type II DiabetesDyslipidemiaNCT02947620Daewoong Pharmaceutical Co. LTD.185
已完成
3 期
A Study of AK104 in the First-line Treatment of Locally Advanced Unresectable or Metastatic G/GEJ AdenocarcinomaGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaNCT05008783Akeso610
已完成
3 期
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II DiabetesType II DiabetesDyslipidemiaNCT02586129Yuhan Corporation249