NCT00629681已完成4 期
Efficacy and Safety of Pregabalin in an Open-label, Non-comparative, Flexible-dose Trial With Diabetic Peripheral Neuropathy or Postherpetic Neuralgia
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 217 人开始时间: 2004年11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
- 217
- 试验地点
- 1
- 主要终点
- Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of pregabalin for the treatment of diabetic peripheral neuropathy (DPN) or postherpetic neuralgia (PHN)
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
- 未提供
排除标准
- •Hospitalized patients
- •Neurologic disorders unrelated to DPN or PHN or any severe pain that may confound the assessment of DPN- or PHN-related pain
研究组 & 干预措施
1
Experimental
干预措施: Pregabalin (Drug)
结局指标
主要结局
Correlation between global status (as measured by the Clinical Global Impression of Change [CGIC] and the Patient Global Impression of Change [PGIC]) and changes in pain, anxiety, and sleep parameters
时间窗: Baseline to Week 4
次要结局
- Mean anxiety score from patient's daily anxiety diary(14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28)
- CGIC and PGIC(End of treatment)
- Course of mean pain score of patient's daily pain diary (NRS)(Throughout the study)
- Adverse events(14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28)
- Change from baseline in EuroQOL (as measures by EQ-5D)(End of treatment)
- Mean sleep score from patient's daily sleep interference diary(14 and 7 days before baseline, baseline, and Days 4, 7, 14, and 28)
- Change from baseline in mean anxiety score from patient's daily anxiety diary(End of treatment)
- Change from baseline in Medical Outcomes Study (MOS)-Sleep Scale score(End of treatment)
- Change from baseline in mean sleep score from patient's daily sleep interference diary(End of treatment)
- Change from baseline in Pain Treatment Satisfaction Scale (PTSS) 9 items score(End of treatment)
- Median time to pain response profile(Over the first week)
研究者
研究点 (1)
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