NCT00641719已完成3 期
A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain - Extension Phase
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
- 258
- 试验地点
- 1
- 主要终点
- Number of Participants Who Experienced an Adverse Event (AE)
研究概览
简要总结
The purpose of the study is to investigate safety and efficacy of duloxetine for patients with painful diabetic neuropathy at long-term use.
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
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients who have completed the 13-week treatment in the preceding study (Protocol No. 0715N0831: NCT00552175).
- •Patients who desire to receive continued treatment with LY248686 from the preceding study.
- •Patients with latest glycosylated hemoglobin (HbA1c) ≤9.0% before Visit
- •Patients who can provide written consent in person.
排除标准
- •Patients who concurrently have serious cardiovascular, hepatic, renal, respiratory, or blood disease, or symptomatic peripheral vascular disease, and thus are considered inappropriate to be included in the study.
- •Pregnant patients or women who desire to become pregnant during the study period, and breast feeding patients.
- •Other patients judged by the investigator/subinvestigator to be inappropriate as a subject in this study.
研究组 & 干预措施
Duloxetine 40 mg
Experimental
Duloxetine 40 milligrams (mg) once daily (QD), orally (PO), 1 year
干预措施: Duloxetine hydrochloride (Drug)
Duloxetine 60 mg
Experimental
Duloxetine 60 mg QD, PO, 1 year
干预措施: Duloxetine hydrochloride (Drug)
结局指标
主要结局
Number of Participants Who Experienced an Adverse Event (AE)
时间窗: baseline through 1 year
See the Reported Adverse Events section for details.
次要结局
- Patient Global Impression of Improvement (PGI-I) Scale at One Year Endpoint.(1 year)
- Brief Pain Inventory (BPI) Interference Scores at One Year Endpoint(1 year)
- Beck Depression Inventory-II (BDI-II) Total Score at One Year Endpoint(1 year)
- Change From Baseline to One Year Endpoint in Beck Depression Inventory-II (BDI-II) Total Score(baseline, 1 year)
- Brief Pain Inventory (BPI) Severity Scores at One Year Endpoint(1 year)
- Change From Baseline to One Year Endpoint for Patient Global Impression of Improvement (PGI-I) Scale(baseline, 1 year)
- Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Interference Scores(baseline, 1 year)
- Change From Baseline to One Year Endpoint in Brief Pain Inventory (BPI) Severity Scores(baseline, 1 year)
研究者
研究点 (1)
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