NCT00291148已完成3 期
A Comparative Single Center, Randomized Neuropathic Pain Assessment Study Involving Patients With Clinically Definite Multiple Sclerosis (MS) Receiving Treatment With Either Pregabalin or Paroxetine
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
- 75
- 试验地点
- 1
- 主要终点
- Pain levels (as determined by weekly Visual Analogue Scale for pain)
研究概览
简要总结
This is a comparative drug trial involving patients with clinically definite Multiple Sclerosis and documented neuropathic pain. Patients will be randomized to receive treatment with either paroxetine or pregabalin. After dose titration, participants will complete various pain scale assessments at several points during the study in order to determine the effectiveness of their assigned pain medication.
详细描述
General Objective:
To determine the effectiveness of drug treatment in the management of MS-induced neuropathic pain.
Specific Objectives:
- Comparatively assess the effectiveness and safety profile of pregabalin (Lyrica) and paroxetine (Paxil) in managing MS-induced neuropathic pain.
- Comparatively assess the effectiveness of pregabalin (Lyrica) and paroxetine (Paxil) in improving the quality-of-life associated with MS-induced neuropathic pain.
Study Design:
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Patients presenting with symptoms of neuropathic pain as determined by clinician, with a minimum VAS pain score of 40mm as determined by a baseline score (0mm = no pain, 100mm = worst pain).
- •Male and female patients between the ages of 18 and 65 years old.
- •Clinically definite multiple sclerosis as defined by clinical history review, neurological examination and positive MRI.
- •EDSS scores of < 6.
- •No known hypersensitivity to the study medications.
- •Negative serum pregnancy test for all female patients of childbearing age; not currently breastfeeding.
- •Not currently treated with pregabalin, gabapentin, paroxetine or another SSRI.
- •No previous treatment failures with pregabalin or paroxetine.
- •Baseline creatinine clearance (Clcr) of > 50mL/min.
- •No significant hepatic insufficiency.
- •If on other pain medications, must be on stable dose for at least 6 months and other medications must not elicit significant drug-drug interactions with study medications.
排除标准
- 未提供
研究组 & 干预措施
Paroxetine
Active Comparator
干预措施: paroxetine (Drug)
pregabalin
Active Comparator
干预措施: pregabalin (Drug)
结局指标
主要结局
Pain levels (as determined by weekly Visual Analogue Scale for pain)
时间窗: 8 weeks
次要结局
- Short-Form 36 health outcomes survey (SF-36)(8 weeks)
- Short-form McGill Pain Questionnaire (SF MPQ)(8 weeks)
- Patient-rated Global Impression of Change (PGIC)(8 weeks)
研究者
研究点 (1)
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