A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Diabetic Neuropathic Pain
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 8
- 主要终点
- 24-hour Average Pain Score
研究概览
简要总结
To evaluate the safety and efficacy of ABT-652 compared to Placebo in subjects with diabetic neuropathic pain. People with diabetes can, over time develop nerve damage throughout the body with symptoms such as pain, tingling, or numbness (loss of feeling) in the hands, arms, feet and legs.
详细描述
A double blind, randomized, active- and placebo-controlled 13-week study. Duloxetine is added to evaluate assay sensitivity.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subject is between the ages of 18-75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months.
- •Subject must have a mean average score of greater than 4 on the 24 hour average pain score (0-10 numerical rating scale) prior to the Baseline Visit.
- •Subject has been on a medication for diabetic neuropathic pain for the past 3 months.
排除标准
- •Subject has clinically symptomatic neuropathic pain conditions that cannot be distinguished from Diabetic Neuropathic Pain or interfere with the pain assessments of Diabetic Neuropathic Pain.
- •A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with Diabetic Neuropathic Pain assessments or other functions.
- •Subject has clinically significant abnormalities in clinical laboratory tests.
- •Subject has taken an opioid chronically, excluding tramadol within the last 3 months prior to Screening.
研究组 & 干预措施
ABT-652 6 mg
ABT-652 capsules - twice daily
干预措施: ABT-652 6 mg (Drug)
ABT-652 12 mg
ABT-652 capsules twice daily
干预措施: ABT-652 12 mg (Drug)
ABT-652 12 mg - 18 mg
ABT-652 capsules twice daily
干预措施: ABT-652 12 mg - 18 mg (Drug)
Placebo
Placebo capsules twice daily
干预措施: Placebo (Drug)
Duloxetine
Duloxetine capsules once daily
干预措施: Duloxetine (Drug)
结局指标
主要结局
24-hour Average Pain Score
时间窗: 12 weeks
Weekly mean of 24-hour average pain score measured by a 11-point Numeric Rating Scale completed on subject's daily diary.
次要结局
- Neuropathic Pain Symptom Inventory(12 weeks)
- Brief Pain Inventory(12 weeks)
- Neuropathic Pain Impact on Quality of Life Questionnaire(12 weeks)
- Patient Global Impression of Change(12 weeks)
- EuroQuality of Life - 5 Dimension -5 Level(12 weeks)