NCT04846673已完成4 期
Efficacy and Safety of Pregabalin and Alpha-lipoic Acid Combination Versus Each Monotherapy in Patients With Diabetic Peripheral Neuropathy: a Randomized, Parallel, Open-label, Multicenter, Phase IV Clinical Trial (OPTIMUM Trial)
Yuhan Corporation14 个研究点 分布在 1 个国家目标入组 151 人开始时间: 2021年5月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 151
- 试验地点
- 14
- 主要终点
- visual analogue scale (VAS)
研究概览
简要总结
This study is a randomized, parallel, open-label, multicenter, phase IV clinical trial to assess the efficacy and safety of pregabalin and alpha-lipoic acid combination compared with each monotherapy in patients with diabetic peripheral neuropathy for 12 weeks.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 19 to 75
- •type 2 diabetes mellitus with HbA1c (Hemoglobin A1c) ≤ 10 %
- •peripheral (eg. hands, feet) neuropathic pain (eg. abnormal sensations, numbness, pain, etc.) within 3 months (12 weeks)
- •diagnosed with diabetic peripheral neuropathy (DPN)
- •VAS pain score ≥ 40 mm
- •written informed consent
排除标准
- •brittle diabetes mellitus
- •ALT (Alanine Transaminase), AST (Aspartate Transaminase), CPK (Creatine Phosphokinase) level ≥ 3 times the upper limit of normal (UNL) or active liver disease
- •severe renal impairment (eGFR (estimated glomerular filtration rate) < 60 mL/min/ 1.73m2)
- •treated with antiepileptic drugs within 1 week at randomization
- •other nervous system or neuropathic disorders that may affect pain evaluation
- •oral drug administration is not possible, or hypersensitive or allergic to pregabalin, r-thioctic acid tromethamine, thioctic acid, and other excipients
- •pregnant, lactating, or childbearing potential
- •alcoholics, drug abusers, and patients who are difficult to participate in clinical trials due to psychological and emotional problems
- •have participated in other clinical trials within 30 days at screening
研究组 & 干预措施
Pregabalin and alpha-lipoic acid combination therapy
Experimental
Alpha-lipoic acid 480 mg/tablet once daily before breakfast and Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
干预措施: Pregabalin 150mg + Alpha-lipoic acid 480mg (Drug)
Pregabalin monotherapy
Experimental
Pregabalin 150 mg/tablet once daily before bedtime will be administrated for 12 weeks.
干预措施: Pregabalin 150mg (Drug)
Alpha-lipoic acid monotherapy
Active Comparator
Alpha-lipoic acid 480 mg/tablet once daily before breakfast will be administrated for 12 weeks.
干预措施: Alpha-Lipoic Acid 480mg (Drug)
结局指标
主要结局
visual analogue scale (VAS)
时间窗: 12 weeks
次要结局
- visual analogue scale (VAS)(6 weeks)
- visual analogue scale (VAS) reduction rate of more than 30%(6 weeks, 12 weeks)
- brief pain inventory Korean version, BPI-K(6 weeks, 12 weeks)
- visual analogue scale (VAS) reduction rate of more than 50%(6 weeks, 12 weeks)
- total symptom score, TSS(6 weeks, 12 weeks)
- 3 level version of Euro-Qol-5 dimensions, EQ-5D-3L(6 weeks, 12 weeks)
- pain detect questionnaire, PD-Q(6 weeks, 12 weeks)
研究者
研究点 (14)
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