NCT01261143已完成3 期
Phase III Randomized, Double-blind Study to Assess the Efficacy and Safety of α-lipoic Acid Versus BK-C-0701 in Subjects With Diabetic Neuropathy
Bukwang Pharmaceutical1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2010年8月最近更新:
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
- 164
- 试验地点
- 1
- 主要终点
- TSS
研究概览
简要总结
The purpose of this study is to determine the:
Primary end point
- change of Total symptom score
Secondary end point
- neurological test
详细描述
total symptom score shall be calculated from the data of burning, numbness, stabbing pain, paraesthesiae.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year and is well-controlled.
- •Patient with symmetric sensory-motor Diabetic Neuropathy which is above stage 2
- •Result of pin-prick test is 'absent' or 'reduced'
- •HbA1C <10%
- •Total Symptom Score ≥ 4 points
- •At least 1 of the 4 symptoms of the TSS must have occurred continuously over the last 3 months.
- •Patient over 19 years of age
- •Female who is postmenopausal or is willing to use an effective method of contraception during the study (Effective method=IUD, spermicide with condom, abstinence) or is surgically sterile (underwent a total hysterectomy or bilateral tubal ligation).
排除标准
- •Patient who has Proximal asymmetric neuropathy, cranial neuropathies, truncal radiculopathy, diabetic plexopathies, acute or active mononeuropathies (cranial neuropathies, post-herpes neuralgias)
- •Patient who has Neuropathy from alcohol, drug (cisplatin, taxol , etcs), malignant cancer or has a medical history of nerve system disease such as Parkinson's disease/ epilepsy/ Multiple sclerosis, etcs.
- •Patient who has nerve system disease which can cause sensory loss Myopathy of any cause.
- •Peripheral vascular disease severe enough to cause ischemic ulcers or limb ischemia.
- •Patients with diabetic proliferating retinopathy requiring immediately therapy and impending blindness.
- •Patients with any active neoplastic disease except benign tumor or nonrecurrent malignant tumor for 5 years.
- •Patients with clinically significant cardiac, pulmonary, gastrointestinal, haematological, or endocrine disease that may confound interpretation of the study results or prevent the patient from completing the study.
- •Patients with atrial fibrillation.
- •Patients who have had organ transplants of any kind.
- •Patients with significant hepatic or renal disease (AST, ALT or GGT >2 times normal, serum creatinine >1.8 mg/dL (>159 mmol/l) for males or >1.6 mg/dL (>141 mmol/l) for females).
- •Patients with a recent history (within last 12 months) of drug or alcohol abuse.
- •Use of any investigational drug (participation in a clinical trial) within last 1 month.
- •History of severe or anaphylactic reaction to drugs, sulfur or biologic products.
- •Recent (within last 3 months) ketoacidosis or hypoglycaemia, necessitating hospital admission.
- •Existing foot ulcers.
- •Pregnant or lactating females
- •History of allergic reaction to the study medication or its excipients.
- •Psychiatric, psychological, or behavioural symptoms that would interfere with the patient's ability to participate in the trial.
- •Patient who is not suitable to trial by investigator judgment.
- •Patient who does not write informed consent prior to start of trial and cannot comply with the trial requirements.
- •Antioxidant therapy (vitamins E > 400 IU, C > 200 mg, and beta-Carotene > 30 mg) or pentoxyphylline within last 1 month before start of trial.
- •Use of thioctic acid (> 50 mg), evening primrose oil or any other gamma-linolenic acid containing substance within the last 3 months.
- •Use of analgesic within >5times of a half-life before administration of investigational medication.
- •Use of anticonvulsants(include Pregabalin), antidepressants within 4 weeks before administration of investigational medication.
研究组 & 干预措施
BK-C-0701, diabetic neuropathy
Experimental
干预措施: BK-C-0701 (Drug)
alpha lipoic acid, diabetic neuropathy, capsule
Active Comparator
干预措施: BK-C-0701 (Drug)
结局指标
主要结局
TSS
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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