NCT05624853已完成4 期
A Randomized, Active-controlled, Parallel, Open-label, Multicenter, Phase 4 Study to Compare the Efficacy and Safety of Pregabalin Sustained Release Tablet and Pregabalin Immediate Release Capsule in Type II Diabetic Patients With Peripheral Neuropathic Pain
Yuhan Corporation8 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2020年5月12日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 8
- 主要终点
- Change from baseline to week 8 in Visual Analogue Scale(VAS)
研究概览
简要总结
This study is to compare the efficacy and safety of pregabalin sustained release tablet and pregabalin immediate release capsule in type II diabetic 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
- None
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 19 years, < 75 years
- •VAS score for diabetic peripheral neuropathy pain ≥ 30
- •Patients who have been administering pregabalin immediate release capsule 150 mg/day for more than 4 weeks
- •Type II DM patient and HbA1c ≤ 10 %
- •Written informed consent
排除标准
- •Patient with hypersensitivity to pregabalin
- •Patient on anti-epileptic drugs
- •Patients with pain caused by other factors than diabetic peripheral neuropathy
- •Patients undergoing eGFR <30 mL/min/1.73 m2 (MDRD) at screening
- •AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range) or active liver disease
- •Drug-abusing patient
- •Severe depression or uncontrolled abnormal mood and behavioral changes
- •Pregnant and breast-feeding woman
- •Patients who participated in other clinical trials for investigational products within 30 days of screening
- •Patients deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
pregabalin sustained release tablet
Experimental
pregabalin sustained release tablet 150mg qd for 8weeks
干预措施: pregabalin sustained release tablet (Drug)
pregabalin immediate release capsule
Active Comparator
pregabalin immediate release capsule 75mg bid for 8weeks
干预措施: pregabalin immediate release capsule (Drug)
结局指标
主要结局
Change from baseline to week 8 in Visual Analogue Scale(VAS)
时间窗: Baseline/Week 8
次要结局
- Change from baseline to week 8 in Clinician Global Impression of Change(CGIC)(Baseline/Week 8)
- Change from baseline to week 8 in Patients Global Impression of Change(PGIC)(Baseline/Week 8)
- Dose and frequency of Rescue medication(Acetaminophen)(Baseline/Week 8)
- Change from baseline to week 8 in Daily Sleep Interference Scale(DSIS)(Baseline/Week 8)
- Change from baseline to week 8 in Morisky Medication Adherence Scale 8-item version(MMAS-8)(Baseline/Week 8)
- Change from baseline to week 8 in Quality of Life(EQ-5D)(Baseline/Week 8)
- Number and proportion of subjects with adverse event(Baseline/Week 8)
研究者
研究点 (8)
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