A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled Study Assessing the Efficacy and Tolerability of SKL11197 for the Pain of Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 13
- 主要终点
- Relief of diabetic neuropathy pain
研究概览
简要总结
Primary Objective: To evaluate the efficacy of SKL11197 for the treatment of diabetic peripheral neuropathy pain (DPN).
Secondary Objective: To evaluate the safety and tolerability of SKL11197 in subjects with painful diabetic peripheral neuropathy.
Primary Efficacy Endpoint: The primary efficacy outcome variable will be the time to exit from the double-blind phase because of inadequate pain relief.
详细描述
This study is a double-blind, placebo controlled study with three phases;
- a pre-study medication washout/screening phase upto 3 weeks
- a 3-week, open label phase
- a 6-week double-blind phase At the end of 3-week in the open label phase, subjects may enter the double-blind phase if they meet the eligibility criteria.
Eligible subjects will be randomized in a blinded fashion either to continue with SKL11197 at 300 mg TID or to take the same number of placebo capsules.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Diagnosis of Type 1 or Type 2 diabetes mellitus for at least 1 year
- •At least moderate pain, ≥ 40mm on a 100mm VAS at the end of washout phase (in absence of any analgesic);
- •HbA1c < 12 % at Screening
- •Daily pain attributed to diabetic neuropathy for least 3 months prior to Screening on the basis of history and physical examination documenting peripheral neuropathy.
- •Pain from diabetic neuropathy should be identifiable by the subject. Pain must involve the lower extremities and be bilateral.
- •Females must be of non-childbearing potential (defined as either surgically sterile or at least one year postmenopausal, Menopause is defined as 1 year since last menstrual period with associated subjective sensations), or,
- •If capable of bearing children, females must use a double-barrier method of contraception, or an intrauterine device. Females capable of bearing children must have negative serum pregnancy (beta-HCG) test at Screening and negative urine pregnancy on Day 1.
排除标准
- •Pregnant or lactating females
- •Subjects with BMI over 40
- •Pain due to symptomatic peripheral vascular disease (e.g. intermittent claudication)
- •Subjects with known clinically significant decreased blood flow to the extremities
- •Subjects cannot have pain from other sources that can confuse the assessment of the diabetic neuropathic pain
- •Peripheral neuropathy attributable to other causes such as alcoholism, connective tissue disease, or toxic exposure;
- •Have profound autonomic dysfunction, or brittle diabetes;
- •Evidence of amputations (including toes), open ulcers, or Charcot joint.
研究组 & 干预措施
SKL11197
This arm is the experimental drug (SKL11197) arm. Patients will be randomized to this arm.
干预措施: SKL11197 (Drug)
Placebo
This arm is the placebo comparator arm. Patients will be randomized to this arm.
干预措施: Placebo (Drug)
结局指标
主要结局
Relief of diabetic neuropathy pain
时间窗: 24 hours
次要结局
- Average daily pain score(24 hours)