NCT00407511已完成4 期
A Prospective, Open Label, Multi-Center, Study Of Pregabalin In The Treatment Of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy, Postherpetic Neuralgia, HIV-Related Peripheral Neuropathic Pain And Chemotherapy Induced Peripheral Neuropathic Pain
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2007年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
研究概览
简要总结
Management of neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus-related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients who are diagnosed with neuropathic pain associated with diabetic peripheral neuropathy, post-herpetic neuralgia, human immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy.
排除标准
- •Severe Pain associated with conditions other than Diabetic Peripheral Neuropathy, Post-Herpetic Neuralgia, Human Immunodeficiency virus related peripheral neuropathy, and chemotherapy induced peripheral neuropathy that may confound assessment or self evaluation of the neuropathic pain.
- •Skin Condition in the affected dermatome that (in the judgment of the investigator) could alter sensation.
研究组 & 干预措施
Pregabalin
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Change From Baseline to End of Treatment (EOT) in Weekly Mean Pain Score on the Daily Pain Rating Scale (DPRS)
时间窗: Baseline, End of Treatment
11 point Likert scale: range 0 to 10 (no pain to worst possible pain) over past 24 hours. Baseline score = mean score of preceding 7 days (including Visit 2). Final end of treatment (EOT) pain score = mean pain score from last 7 post-Baseline days preceding Visit 8 (Week 12) or last 7 days on study drug for those who did not complete the study. Change = mean at EOT minus mean at Baseline.
次要结局
- Change From Baseline in Visual Analogue Scale for Pain (VAS-pain)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 8, Week 12, EOT/LOCF)
- Change From Baseline in Mean Pain Score on the Daily Pain Rating Scale (DPRS)(Week 4, Week 8, Week 12)
- Change From Baseline in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Interference Index Scores(Baseline, Week 8, Week 12, End of Treatment/Last Observation Carried Forward (EOT/LOCF))
- Pain Treatment Satisfaction Scale (PTSS): Satisfaction With Current Pain Medication(Baseline, Week 8, Week 12, EOT/LOCF)
- Clinical Global Impression of Change (CGIC)(End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment))
- Change From Baseline (BL) in Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores(Baseline, Week 8, Week 12, EOT/LOCF)
- Pain Treatment Satisfaction Scale (PTSS): Impact of Current Pain Medication(Baseline, Week 8, Week 12, EOT/LOCF)
- Change From Baseline in Global Anxiety Visual Analogue Scale (GA-VAS)(Baseline, Week 8, Week 12, EOT/LOCF)
- Patient Global Impression of Change (PGIC)(End of Treatment/ Last Observation Carried Forward (Week 12 or last post-baseline assessment))
- Change From Baseline in Mean Daily Sleep Interference Score (DSIS)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, EOT/LOCF)
研究者
研究点 (1)
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