NCT01224353Unknown2 期
Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Thioctacid Oral Tablet 600mg Once Daily in Chinese Diabetic Patients With Distal Symmetric Polyneuropathy
NovaMed Pharmaceuticals Inc.5 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2010年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- To evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP)
研究概览
简要总结
The purpose of the study is to evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must fulfil all of the following criteria to be appropriate to enter into Registry (Visit 2)
- •Provision of informed consent
- •Females and males aged from 18 to 75 (inclusive), who were definitely diagnosed with diabetes
- •HbA1C< 10％
- •Moderate neuropathy according to Neuropathy Disability Score (NDS) >= 4 points. Difference in score between left and right foot is not to be higher than 2 points
- •Total Symptom Score (TSS) > 6.5 points
- •At least one of the four symptoms of the TSS has occurred continuously over the last 3 months before screening
- •Other concomitant treatments (the drugs and their dosage) have been stable over 1 month before screening Subjects must fulfil all of the following criteria before randomization：
- •TSS > 5 points
- •TSS range (maximum TSS - minimum TSS during Run-in Period) < 3 points during the Run-in Period
- •Compliance in Run-in Period > 85%
排除标准
- •Neurologic disease other than diabetic neuropathy that may produce weakness, sensory loss, or autonomic symptoms or test abnormality
- •Peripheral vascular disease severe enough to cause intermittent claudication or ischemic ulcers
- •Patients who have been hospitalized due to glucopenia or ketoacidosis in the last 3 month
- •Present ulcers on lower limbs of any cause
- •Antioxidant therapy within the last 1 month before screening (Vitamin E> 400IU, Vitamin C> 200mg once daily for continuous 2 weeks)
- •Any ALA therapy within the last1 month before screening
- •Opioid analgesic therapy within the last 1 month before screening
- •History of mental, psychological or behavioral conditions rendering the patient unable to follow the protocol
- •History of malignant tumors in the past 5 years except for basal cell carcinoma
- •Any severe systematic diseases, at the investigator's discretion, which will make it undesirable for the patient to participate in the trial or which could jeopardize compliance with the trial protocol,
- •ALT or AST > 2.5 ´ upper limit of reference range
- •Cr > 1.8mg/dL ( > 159µmol/L) for males or > 1.6mg/dL ( > 141µmol/L) for females
- •History of hypersensitive to the active ingredients or excipients of ALA
- •Participation in a clinical study or treatment with a non-approved experimental medication in the last 1 month
- •Pregnant or breast-feeding women, or women of childbearing age without appropriate contraception measures
研究组 & 干预措施
Thioctacid Oral Placebo Tablet
Placebo Comparator
干预措施: Placebo (Other)
Thioctacid Oral Tablet
Active Comparator
干预措施: lipoic acid (Drug)
结局指标
主要结局
To evaluate the efficacy on overall neuropathic sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with distal symmetric polyneuropathy (DSP)
时间窗: 6 weeks
Changes from baseline in Total Symptom Score (TSS) from week 1 to week 6 will be computed and summarized in an Area Under the Curve (AUC).
次要结局
- To evaluate each sensory symptom improvement of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP(6 weeks)
- To evaluate onset time of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP(6 weeks)
- To evaluate response rate of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP(6 weeks)
- To evaluate the tolerability and safety of Thioctacid tablet 600mg once daily vs. placebo in 6-weeks' treatment in Chinese diabetic patients with DSP(6 weeks)
研究者
研究点 (5)
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