NCT01057693已完成3 期
A PHASE 3B MULTICENTER, DOUBLE-BLIND, RANDOMIZED WITHDRAWAL EFFICACY AND SAFETY STUDY OF PREGABALIN IN THE TREATMENT OF PATIENTS WITH INADEQUATELY TREATED PAINFUL DIABETIC PERIPHERAL NEUROPATHY
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.163 个研究点 分布在 1 个国家目标入组 633 人开始时间: 2010年3月31日最近更新:
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
- 633
- 试验地点
- 163
- 主要终点
- Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
研究概览
简要总结
Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.
排除标准
- •Patients with other pain conditions cannot participate.
研究组 & 干预措施
pregabalin (Lyrica)
Experimental
干预措施: pregabalin (Lyrica) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Single-Blind Baseline in Mean Pain Score at Week 19 During Double-Blind Phase
时间窗: SB Baseline, Week 19 (DB Phase)
Mean pain score was defined as the mean of the last 7 daily diary pain ratings. Participants rated their DPN pain over the past 24 hours on an 11-point numeric rating scale ranging from 0 = no pain to 10 = worst possible pain. A rating of 1-3 was considered as mild pain; 4-6 = moderate pain; and 7-10 = severe pain. SB baseline refers to the last 7 pain diary entries up to and including Day 1.
次要结局
- Weekly Mean Sleep Interference Score (Double-Blind Phase)(DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- Change From Single-Blind Baseline in Mean Pain Score at Week 6 During Single-Blind Phase(SB Baseline, Week 6 (SB Phase))
- Time to Loss of Pain Response (Double-Blind Phase)(SB Baseline up to Week 19)
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Double-Blind Phase)(Week 19)
- Weekly Mean Pain Scores (Single-Blind Phase)(Week 1, 2, 3, 4, 5, 6)
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Single-Blind Phase)(Week 6)
- Endpoint Mean Sleep Interference Score (Single-Blind Phase)(Week 6)
- Hospital Anxiety and Depression Scale (HADS) (Single-Blind Phase)(SB Baseline, Week 6)
- Medical Outcomes Study -Sleep Scale (MOS-SS) (Single-Blind Phase)(SB Baseline, Week 6)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Double-Blind Phase)(Week 19)
- Weekly Mean Sleep Interference Score (Single-Blind Phase)(SB Baseline, Week 1, 2, 3, 4, 5, 6)
- Endpoint Mean Sleep Interference Score (Double-Blind Phase)(Week 19)
- Patient Global Evaluation of Study Medication (GESM) (Double-Blind Phase)(Week 19)
- Weekly Mean Pain Scores (Double-Blind Phase)(DB Baseline, Week 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19)
- Percentage of Participants With At Least 30 Percent and 50 Percent Reduction in Mean Pain Score (Double-Blind Phase)(Week 19)
- Patient Global Impression of Change (PGIC) (Single-Blind Phase)(Week 6)
- Patient Global Impression of Change (PGIC) (Double-Blind Phase)(Week 19)
- Number of Participants With Optimal Sleep Assessed Using Medical Outcomes Study-Sleep Scale (MOS-SS) (Single-Blind Phase)(SB Baseline, Week 6)
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Double-Blind Phase)(Week 19)
- Pain Visual Analog Scale (VAS) (Single-Blind Phase)(SB Baseline, Week 6)
- Pain Visual Analog Scale (VAS) (Double-Blind Phase)(Week 19)
- Brief Pain Inventory-Short Form (BPI-sf) (Single-Blind Phase)(SB Baseline, Week 6)
- Hospital Anxiety and Depression Scale (HADS) (Double-Blind Phase)(Week 19)
- Quality of Life Questionnaire- Diabetic Neuropathy (QOL-DN) (Single-Blind Phase)(SB Baseline, Week 6)
- Brief Pain Inventory-Short Form (BPI-sf) (Double-Blind Phase)(Week 19)
- Patient Global Evaluation of Study Medication (GESM) (Single-Blind Phase)(Week 6)
研究者
研究点 (163)
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