Randomized, Double-blinded, Double-dummy, Active-controlled, Multi-center Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of KW21052 for 8 Weeks Compared to Pregabalin (Lyrica) in the Diabetic Patients With Neuropathic Pain
试验速览
- 阶段
- 3 期
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Numerical pain rating scale (NRS)
研究概览
简要总结
Diabetic neuropathy is known to be the most common complication of diabetes, although the estimated prevalence is highly variable, ranging from 1.6 to 90%. Also, chronic pain is accompanied with sleep disorders, depression, and anxiety, thereby impairing quality of life and increasing societal costs. Pregabalin is one of proven and marketed oral medicine to manage the chronic neuropathic pain in diabetic patients. This study is designed as a randomized controlled trial to demonstrate that the efficacy of KW21052 in pain reduction measured by the weekly mean pain score on the numerical pain rating scale (NRS) at the 8th week of intervention is inferior to that of Lyrica.
详细描述
Patient Reported Outcomes (PRO) using validated questionnaires and patient diaries will be assessed for efficacy analysis.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 and 2 diabetic patients
- •Patients diagnosed with diabetic, distal, symmetrical, and sensorimotor polyneuropathy
- •40mm and more on VAS
- •4 and more on NRS
- •Informed consented patients
排除标准
- •Participating in another clinical trial
- •Pregnancy or lactating
- •Sensitivity to pregabalin
- •Significant underlying disease or disorders
- •Prohibited concomitant medications
- •Significant laboratory abnormalities
研究组 & 干预措施
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
干预措施: KW21052 (Drug)
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
干预措施: Lyrica (low dose) (Drug)
KW21052
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with KW21052 300mg and Placebo of Lyrica for intervention period of 8 weeks.
干预措施: Placebo of Lyrica (Drug)
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
干预措施: Lyrica (Drug)
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
干预措施: Lyrica (low dose) (Drug)
LYRICA
This arm will be pre-treated with Lyrica 150mg (75mg bid) for titration period of 1 week and then be treated with Lyrica 300mg (150mg bid) and Placebo of KW21052 300mg for intervention period of 8 weeks.
干预措施: Placebo of KW21052 (Drug)
结局指标
主要结局
Numerical pain rating scale (NRS)
时间窗: After 8 weeks of intervention
次要结局
- Change on on the numerical pain rating scale (NRS)(From baseline to 8th week of intervention)
- Response rate(From baseline to 4th and 8th week of intervention)
- Clinical Global Impression of Change (CGIC)(After 8 weeks of intervention)
- Improved quality of life (QoL)(After 4 and 8 weeks of intervention)
- Drug compliance(During 8 weeks of intervention)
- Adverse events(Every clinic visit)