NCT00266643已完成4 期
A Comparison of Strategies for Switching Patients From Amitriptyline to Duloxetine for the Management of Diabetic Peripheral Neuropathic Pain
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 21
- 主要终点
- Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded.
研究概览
简要总结
This study is to compare the tolerability of different methods for switching from another medication to duloxetine for the management of diabetic nerve pain. The primary objective is to compare the most gradual method with the most abrupt method, to see if they have different tolerability.
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
- Double
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
- •You must have been diagnosed with Diabetic Peripheral Neuropathic Pain.
- •You must have been taking the same dose of amitriptyline once daily at bedtime for at least four (4) weeks.
- •You must have stable glycemic control.
- •You must be able to visit the doctor's office once a week for ten (10) weeks.
排除标准
- •You are in the acute recovery phase following myocardial infarction.
- •You have Major Depressive Disorder, an Anxiety Disorder, or some other psychiatric illnesses that the doctor will ask you about.
- •You are allergic to amitriptyline or duloxetine.
- •You are currently taking an anticonvulsant, cisapride (Propulsid), or if you have taken an opioid for three or more consecutive days during the 14 days prior to Visit
- •You have uncontrolled narrow angle glaucoma.
结局指标
主要结局
Subscale of the UKU side effect rating scale to be measured during the switch period. The weeks during which the switch occurs are blinded.
次要结局
- Daily: 24 hr avg pain, worst pain, night pain; NSAID & acetaminophen use.
- Weekly: Leeds Sleep Evaluation Questionnaire, Brief Profile of Mood States, Clinical Global Impression of Severity. Visits 2, 7, 11: Treatment Satisfaction Questionnaire for Medic
研究者
研究点 (21)
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