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临床试验/NCT00322621
NCT00322621已完成4 期

Maintenance of Effect of Duloxetine 60 mg Once Daily in Patients With Diabetic Peripheral Neuropathic Pain

Eli Lilly and Company1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2006年4月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
216
试验地点
1
主要终点
Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To determine if duloxetine 60 mg once daily can work up to 6 months in treating pain from Diabetic Neuropathy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •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, or blood disorder, seizure disorder, problems with peripheral vascular disease, or other medical conditions or psychiatric conditions that would hinder your participation or be 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 with 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

Duloxetine

Experimental

All subjects receive 30 mg once daily (QD), by mouth (per os - PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months. Patients beginning maintenance at the 60 mg QD dose could be increased to the 120 mg QD level if they did not maintain appropriate level of response throughout the maintenance period.

干预措施: Duloxetine (Drug)

结局指标

主要结局

Change From Baseline (Week 8) in Brief Pain Inventory (BPI) 24-hour Average Pain Item Score at Week 34 Endpoint

时间窗: Baseline (Week 8), Week 34

Maintenance effect of duloxetine 60 mg in patients with diabetic peripheral neuropathic pain (DPNP) was assessed by the change in BPI 24-hour average pain item score from baseline of the maintenance therapy arm (week 8) to 34 week endpoint in patients who achieved at least a 30 percent reduction on the BPI 24-hour average pain item after 8 weeks of acute therapy (Acute Therapy Phase). BPI is 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

  • Maintenance Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item(Baseline (Week 0), Week 34)
  • Rescue Arm: Number of Patients With a ≥50% Reduction From Baseline (Week 0) in Brief Pain Inventory 24-hour Average Pain Item(Baseline (Week 0), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Worst Pain Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Least Pain Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Pain Score at 34 Week Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Pain Right Now Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: General Activity at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Mood at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Walking Ability at 34 Week Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Normal Work at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Relations With Other People at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Sleep at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Interference Score: Enjoyment of Life at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Brief Pain Inventory Average Interference at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint(Week 34)
  • Rescue Arm: Patient's Global Impressions of Improvement (PGI-I) at Week 34 Endpoint(Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Clinical Global Impressions of Severity (CGI-S) at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Sensory Portion of the Short-Form McGill Pain Questionnaire at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Maintenance Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Rescue Arm: Change From Baseline (Week 8) in Beck Depression Inventory-II (BDI-II) Total Score at Week 34 Endpoint(Baseline (Week 8), Week 34)
  • Number of Participants Discontinuing in the Acute Phase(Baseline (Week 0) to Week 8)
  • Number of Participants Discontinuing in Maintenance / Rescue Phase(Baseline (Week 8) to Week 34)
  • Change From Baseline in Vital Signs: Heart Rate at Week 34 Endpoint(Baseline (Week 0), Week 34)
  • Change From Baseline (Week 0) in Vital Signs: Diastolic Blood Pressure at Week 34 Endpoint(Baseline (Week 0), Week 34)
  • Change From Baseline (Week 0) in Vital Signs: Systolic Blood Pressure at Week 34 Endpoint(Baseline (Week 0), Week 34)
  • Change From Baseline (Week 0) in Vital Signs: Weight at Week 34 Endpoint(Baseline (Week 0), Week 34)

研究者

申办方类型
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研究点 (1)

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