A Phase 3b Multicenter, Double-blind, Randomized, Placebo-controlled Cross-over Efficacy And Safety Study Of Pregabalin In The Treatment Of Patients With Painful Diabetic Peripheral Neuropathy And Pain On Walking
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 217
- 试验地点
- 45
- 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
The intent of this study is to treat subjects with painful Diabetic Peripheral Neuropathy (DPN) who also have pain on walking and to determine whether or not pregabalin demonstrates improvement relative to placebo on the following: reducing DPN pain, reducing pain on walking, and providing other benefits associated with daily activities and quality of life.
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
- •Men or women who are at least 18 years old.
- •Diagnosis of painful diabetic peripheral neuropathy.
- •Pain on walking.
排除标准
- •Inability to walk 50 feet on a flat surface.
- •Pain on walking due to conditions other than diabetic peripheral neuropathy.
研究组 & 干预措施
Pregabain
干预措施: Pregabalin (Drug)
Placebo
干预措施: placebo (Other)
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 6 and 11)
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 each evening before bedtime (6.00 pm to midnight) on the telephone via Interactive Voice Recognition System (IVRS). The endpoint mean pain score was defined as the mean of the last 7 daily diary pain ratings while taking study medication 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.
DPN Pain on Walking Based on a 11-point NRS of Each Treatment Period (Week 6 of Each Treatment Period)
时间窗: End of Period (includes both Visits 6 and 11)
The post-test DPN pain on walking NRS consisted of an 11-point numeric scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Participants described their DPN pain in their legs and/or feet while walking during the 50-foot walk test by choosing the appropriate number between 0 and 10. The post-test DPN pain on walking NRS was completed by the participant using paper-pen administration immediately after completing the 50-foot walk test at the end of 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 6 and 11))
- Walk 12 Questionnaire Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk Quality of Life-Diabetic Neuropathy (Norfolk QOL-DN) Total Quality of Life (TQOL) Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- 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 6 and 11))
- 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 6 and 11))
- 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 6 and 11))
- BPI-sf Score for Pain-Interference With Walking Ability at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Daytime Total Activity Counts Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Steps Per Day Measured by Actigraphy Over the Last 7 Days of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk QOL-DN Symptoms Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk QOL-DN Activities of Daily Living Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk QOL-DN Physical Functioning / Large Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk QOL-DN Small Fiber Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Norfolk QOL-DN Autonomic Domain Score Measured Over the Last 2 Weeks of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Percentage of Participants With Patient Global Impression of Change (PGIC) Score From Baseline at the End of Period 1 (Week 6)(End of Period 1 (V6))
- Mean Sleep Interference Rating Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- 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 6 and 11))
- Hospital Anxiety and Depression Scale - Depression (HADS-D) Total Score at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))
- Euro QoL-5 Dimensions (EQ-5D) - Health State Profile Utility Scores at the End of Each Treatment Period (Week 6 of Each Treatment Period)(End of Period (includes both Visits 6 and 11))