NCT01345045已完成2 期
A Multicenter, Randomized, Double-Blind, Placebo and Active Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-639 to Placebo in Subjects With Diabetic Neuropathic Pain
AbbVie (prior sponsor, Abbott)35 个研究点 分布在 5 个国家目标入组 193 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 193
- 试验地点
- 35
- 主要终点
- A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
研究概览
简要总结
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.
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 to 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 an average score of greater than or equal to ( ≥) 4 on the 24 hour average pain score (0-10 numerical rating scale) collected over approximately 7 days prior to the Baseline Visit.
排除标准
- •Subject has clinically symptomatic neuropathic pain conditions that can not be distinguished from Diabetic Neuropathic Pain (DNP) or interfere with the pain assessments of DNP.
- •A subject has newly diagnosed or clinically significant medical conditions or mental disorders that would preclude participation or would interfere with DNP assessments or other functions.
- •Subject has clinically significant abnormalities in clinical laboratory tests.
研究组 & 干预措施
ABT-639
Experimental
ABT-639 twice daily for 6 weeks
干预措施: ABT-639 (Drug)
pregabalin
Active Comparator
pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study
干预措施: pregabalin (Drug)
Placebo
Placebo Comparator
Placebo twice daily for 6 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
A mean of 24-hour average pain score measured by an 11-point Numeric Rating Scale (NRS) based on subject's daily diary
时间窗: Weekly started at Baseline, Week 1, Week 2, Week 4, and Week 6 (End of Study)
Daily questions asked on a hand held diary
次要结局
- Patient's Global Impression of Change(Week 2, Week 4 and Week 6 (End of Study))
- Brief Pain Inventory (BPI) (short form) including Severity and Interference(At each visit up to Week 6 (end of Study))
- Neuropathic Pain Symptom Inventory (NPSI)(Baseline, Week 2, Week 4 and Week 6 (end of Study))
研究者
研究点 (35)
Loading locations...
相似试验
已完成
2 期
A Randomized, Double-blind, Placebo- and Active-controlled Study of the Electric Current Effects of ABT-639 on the Spontaneous Activity of Pain Sensory Receptors in Patients With Diabetic Peripheral NeuropathyDiabetic Neuropathic PainNCT01589432AbbVie (prior sponsor, Abbott)39
尚未招募
不适用
Quantifying Artificial Pancreas-related Changes in Diabetic NeuropathyDiabetes ComplicationsDiabetic NeuropathiesDiabetes Mellitus, Type 1NCT05951283Manchester University NHS Foundation Trust102
已完成
3 期
Cytoflavin in the Treatment of Patients With Diabetic PolyneuropathyDiabetic NeuropathiesNCT04649203POLYSAN Scientific & Technological Pharmaceutical Company216
终止
2 期
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal WoundsDiabetesNCT00598871ReGenTree, LLC12
终止
2 期
A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic PainNeuropathic Pain Associated With Diabetic Peripheral NeuropathyNCT04641273Bayer154