NCT00408993已完成3 期
Duloxetine Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain in China
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
研究概览
简要总结
To determine if duloxetine 60mg up to 120mg daily can work in treating pain from Diabetic Neuropathy.
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
- •Have pain due to bilateral peripheral neuropathy caused by Type I or Type II diabetes with the pain beginning in the feet and present for at least 6 months.
- •May not be pregnant and agree to utilize medically acceptable and reliable means of birth control during participation in the study.
- •Score of 4 or greater on the Brief Pain Inventory on the 24-hour average pain item.
排除标准
- •Glycosylated hemoglobin (A1C) > 12%
- •Severe hepatic disease
- •History of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- •Serious or unstable cardiovascular, hepatic (acute liver injury such as hepatitis or severe cirrhosis), kidney, respiratory, blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or likely to lead to hospitalization during the course of the study.
- •Taking monoamine oxidase inhibitor (MAOI) within 14 days of starting the study or the potential need to take during or within 5 days after discontinuation from the study.
- •Treatment of fluoxetine within 30 days of starting the study.
- •Unstable blood sugar control and uncontrolled or poorly controlled hypertension.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo every day (QD), by mouth (PO) for 12 weeks
干预措施: Placebo (Drug)
Duloxetine
Experimental
60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
干预措施: Duloxetine Hydrochloride (Drug)
结局指标
主要结局
Change From Baseline to 12 Week Endpoint in Brief Pain Inventory 24-hour Average Pain Score
时间窗: Baseline and 12 weeks
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
次要结局
- Change From Baseline to 12 Week Endpoint in Clinical Global Impression of Severity(Baseline and 12 weeks)
- Number of Participants With Treatment-Emergent Adverse Events Reported in >5% of Either Treatment Group by Time of Dosing (Morning or Evening)(over 12 weeks)
- Change From Baseline to 12 Week Endpoint in Brief Pain Inventory (BPI) Worst Pain, Least Pain, and Current Pain Severity and Average Interference Scores(Baseline and 12 weeks)
- Number of Participants Discontinuing Due to Adverse Events(over 12 weeks)
- Time Course of Change in Patient Global Impression - Improvement Scale(baseline, over 12 weeks)
- Change From Baseline to 12 Week Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) (US Based Index Score)(Baseline and 12 weeks)
- Vital Signs - Pulse Rate(Baseline and 12 weeks)
- Change From Baseline to 12 Week Endpoint in Athens Insomnia Scale 8-item and 5-item(Baseline and 12 weeks)
- Vital Signs - Weight(Baseline and 12 weeks)
- Vital Signs - Blood Pressure(Baseline and 12 weeks)
- Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Chloride, High Density Lipoprotein, Sodium, and Triglycerides(Baseline and 12 weeks)
- Statistically Significant Change From Baseline to 12 Week Endpoint in Laboratory Measures - Uric Acid(Baseline and 12 weeks)
研究者
研究点 (1)
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