NCT00552175已完成3 期
A Superiority Study of LY248686 Versus Placebo in the Treatment of Patients With Diabetic Peripheral Neuropathic Pain
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
- 339
- 试验地点
- 2
- 主要终点
- Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
研究概览
简要总结
The purpose of the study is to determine if duloxetine can help patients with painful 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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pain due to bilateral peripheral neuropathy induced by type 1 or 2 diabetes mellitus. The pain must have been present for at least 6 months and be evaluable in feet, legs, or hands.
- •Participants with hemoglobin A1c (HbA1c) less than or equal to 9.0 percent at Visit
- •Participants in whom HbA1c had been measured 42-70 days before Visit 1 and subsequent HbA1c levels have been within +/- 1.0 percent of the level at Visit
- •Participants with a mean of the 24-hour average pain severity scores (round off to a whole number) of 4 or higher, as calculated from the patient diary for 7 days immediately before Visit 2
排除标准
- •Participants who have undergone renal transplant or who are currently on renal dialysis.
- •Participants who have a history requiring pharmacotherapy within the past year or current history of psychiatric disease, such as mania, bipolar disorder, depression, anxiety disorder, or eating disorder.
- •Participants with hypertension with poor control of blood pressure (systolic blood pressure greater than or equal to 180 millimeters of mercury (mmHg) or diastolic blood pressure greater than or equal to 110 mmHg
- •Participants with alanine transaminase (ALT) or aspartate transaminase (AST) greater than or equal to 100 Units per Liter (U/L) at Visit
- •Participants unable to discontinue prohibited concomitant drugs or concomitant therapies after Visit 1.
研究组 & 干预措施
Duloxetine 60
Experimental
duloxetine 60 milligram (mg) taken orally every day
干预措施: Duloxetine hydrochloride - 60 mg (Drug)
Duloxetine 40
Experimental
Duloxetine 40 mg taken orally every day
干预措施: Duloxetine hydrochloride - 40 mg (Drug)
Placebo
Placebo Comparator
placebo comparator taken orally every day
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline at Week 12 in Average Pain Severity Rating Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)
时间窗: Baseline, 12 weeks
Average pain severity was measured using an 11-point numerical rating scale, collected by diaries and expressed as weekly mean. The scale is a self-reported instrument 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
- Patient Global Impression of Improvement Scale at Week 12(Week 12)
- Change From Baseline at Week 12 in Average Pain Severity Rating Score Using Diaries(Baseline, 12 weeks)
- Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, 12 weeks)
- Change From Baseline at Week 12 in Worst Pain Severity Score and Night Pain Severity Score Using Diaries(Baseline, Week 12)
- Patient Global Impression of Improvement Scale at Week 12 in Combined Duloxetine Arms (40 mg + 60 mg)(Week 12)
- Change From Baseline in Brief Pain Inventory Severity Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
- Change From Baseline in Brief Pain Inventory Severity Scores at Week 12(Baseline, Week 12)
- Change From Baseline in Brief Pain Inventory Interference Scores at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
- Change From Baseline in Brief Pain Inventory Interference Scores at Week 12(Baseline, Week 12)
- Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12 for the Combined Duloxetine Arms (40 mg + 60 mg)(Baseline, Week 12)
- Change From Baseline in Beck Depression Inventory-II (BDI-II) Total Score at Week 12(Baseline, Week 12)
研究者
研究点 (2)
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