NCT00553280已完成3 期
An Open-Label Extension Safety And Efficacy Study Of Pregabalin (CI-1008) For Pain Associated With Diabetic Peripheral Neuropathy
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 123 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Summary of Adverse Events
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of the long-term use of pregabalin at doses up to 600 mg/day in patients with painful diabetic peripheral neuropathy who have completed 13 weeks of dosing in Study A0081163
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 completed the 13-week treatment of painful diabetic peripheral neuropathy in Study A
- •Patients must be able to understand and cooperate with study procedures and have signed a written informed consent prior to entering the study
排除标准
- •Patients who experienced serious adverse events in the preceding study (A0081163) that were determined by the investigator or the study sponsor to be causally related to the study medication.
- •Patients exhibiting treatment non-compliance in the preceding study (A0081163)
研究组 & 干预措施
pregabalin
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Summary of Adverse Events
时间窗: 53 weeks
Number of participants with all causality adverse events, serious adverse events, severe adverse events, adverse events resulted in discontinuation, dose reduced or temporary discontinuation. Participants are counted only once per treatment in each row.
次要结局
- Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores(From baseline to 52 weeks or study discontinuation (Study Endpoint))
研究者
研究点 (1)
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