NCT01455415已完成3 期
A Study Of Pregabalin In The Treatment Of Subjects With Painful Diabetic Peripheral Neuropathy With Background Treatment Of Nsaid For Other Pain Conditions
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.56 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2011年12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
- 306
- 试验地点
- 56
- 主要终点
- Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
研究概览
简要总结
This study is to test the effectiveness of pregabalin in treating nerve pain caused by diabetes. The suitable subjects will be patients who also use an non-steroid anti-inflammatory drug for another pain which is not related to the diabetic nerve pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Type 1 or 2 diabetes with painful neuropathy
- •Currently treated with one NSAID (including COX 2 inhibitors) for a co morbid pain condition with a regular dose
- •Meet pre-defined level of pain severity at entrance
排除标准
- •History of failed pregabalin treatment due to lack of efficacy at therapeutic dose
- •Participated in a previous or ongoing pregabalin clinical trial
- •Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain
研究组 & 干预措施
1: Pregabalin
Experimental
干预措施: pregabalin (Drug)
2: Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Average Diabetic Peripheral Neuropathy (DPN) Pain Based on a Numeric Rating Scale (NRS) Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)
时间窗: End of Period (includes both Visits 5 and 9)
The daily pain diary consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their pain during the past 24 hours by having chosen the appropriate number between 0 and 10. Self assessment was performed daily in the evening before bedtime on a telephone via interactive voice recognition system (IVRS) (time window for completion between 6.00 pm to midnight). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study drug in each treatment period - period 1 and period 2, respectively. A rating of 1 - 3 was considered as mild pain; 4 - 6 as moderate pain; and 7 - 10 as severe pain.
次要结局
- Percentage of Participants Achieving 30% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Percentage of Participants Achieving 50% Reduction in Mean DPN Pain Score From Baseline at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Brief Pain Inventory-Short Form (BPI-sf) Score for Pain-Severity Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- BPI-sf Score for Pain-Interference Domain at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Hospital Anxiety and Depression Scale - Anxiety (HADS-A) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- HADS-D Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk QOL-DN Symptoms Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk QOL-DN Activities of Daily Living Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk QOL-DN Small Fiber Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Norfolk QOL-DN Autonomic Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Euro QoL-5 Dimensions (EQ-5D) Mobility Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Self-Care Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Usual Activities Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Pain / Discomfort Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Anxiety / Depression Domain Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Dolan 1997 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- EQ-5D Dolan 2002 Index Summary Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 5 and 9))
- Patient Global Impression of Change (PGIC) Score at the End of Period 1 (Week 6) - Original Scores(End of Period 1 (V5))
- PGIC Score at the End of Period 1 (Week 6) - Categorized Scores(End of Period 1 (V5))
研究者
研究点 (56)
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