Randomized, Double-Blind, Multicenter, Placebo-Controlled Study To Evaluate Efficacy And Safety Of Pregabalin (CI-1008) In The Treatment For Pain Associated With Diabetic Peripheral Neuropathy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 314
- 试验地点
- 1
- 主要终点
- Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
研究概览
简要总结
To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in patients with painful diabetic peripheral neuropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Visual Analogue Scale (VAS) of pain is higher than 40 mm.
- •Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year
排除标准
- •Malignancy within the past 2 years.
- •Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment of neuropathy pain
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
Pregabalin 300 mg/day
干预措施: pregabalin (Drug)
Pregabalin 600 mg/day
干预措施: pregabalin (Drug)
结局指标
主要结局
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores
时间窗: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose.
Number of Responders
时间窗: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
A responder is defined as a subject with a 50% reduction in weekly mean pain score from baseline to study endpoint.
Change From Baseline to Study Endpoint in Mean Weekly Pain Scores by Groups of Subjects With Expected Similar Plasma Concentrations
时间窗: From baseline to Week 13 or up to study discontinuation (Study Endpoint)
Change from baseline: Score at study endpoint minus score at baseline. Study endpoint is defined as the mean of the last seven entries of the daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) while on study medication up to and including day after last dose. Subjects are classified by exposure to pregabalin, which is estimated by creatinine clearance (CLcr).
Change From Baseline at Week 1 in Mean Weekly Pain Scores
时间窗: From baseline to Week 1
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 1. Change from baseline: Score at Week 1 minus score at baseline
Change From Baseline at Week 2 in Mean Weekly Pain Scores
时间窗: From baseline to Week 2
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 2. Change from baseline: Score at Week 2 minus score at baseline
Change From Baseline at Week 3 in Mean Weekly Pain Scores
时间窗: From baseline to Week 3
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 3. Change from baseline: Score at Week 3 minus score at baseline
Change From Baseline at Week 4 in Mean Weekly Pain Scores
时间窗: From baseline to Week 4
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 4. Change from baseline: Score at Week 4 minus score at baseline
Change From Baseline at Week 5 in Mean Weekly Pain Scores
时间窗: From baseline to Week 5
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 5. Change from baseline: Score at Week 5 minus score at baseline
Change From Baseline at Week 6 in Mean Weekly Pain Scores
时间窗: From baseline to Week 6
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 6. Change from baseline: Score at Week 6 minus score at baseline
Change From Baseline at Week 7 in Mean Weekly Pain Scores
时间窗: From baseline to Week 7
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 7. Change from baseline: Score at Week 7 minus score at baseline
Change From Baseline at Week 8 in Mean Weekly Pain Scores
时间窗: From baseline to Week 8
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 8. Change from baseline: Score at Week 8 minus score at baseline
Change From Baseline at Week 9 in Mean Weekly Pain Scores
时间窗: From baseline to Week 9
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 9. Change from baseline: Score at Week 9 minus score at baseline
Change From Baseline at Week 10 in Mean Weekly Pain Scores
时间窗: From baseline to Week 10
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 10. Change from baseline: Score at Week 10 minus score at baseline
Change From Baseline at Week 11 in Mean Weekly Pain Scores
时间窗: From baseline to Week 11
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 11. Change from baseline: Score at Week 11 minus score at baseline
Change From Baseline at Week 12 in Mean Weekly Pain Scores
时间窗: From baseline to Week 12
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 12. Change from baseline: Score at Week 12 minus score at baseline
Change From Baseline at Week 13 in Mean Weekly Pain Scores
时间窗: From baseline to Week 13
The mean change from baseline in mean weekly pain score from daily pain diary using the 11-point numerical rating scale 0(no pain) to 10(worst possible pain) at Week 13. Change from baseline: Score at Week 13 minus score at baseline
次要结局
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Physical Functioning(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Physical(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Bodily Pain(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: General Health Perception(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Social Functioning(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Role Limitations-Emotional(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Vitality(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short Form 36-Item (SF-36) Health Survey: Mental Health(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Mean Sleep Interference Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Affective Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Quantity of Sleep(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Adequacy(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Somnolence(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Overall Sleep Problems Index(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Sensory Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Total Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Visual Analogue Scale Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Short-Form McGill Pain Questionnaire: Present Pain Intensity Scores(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Disturbance(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Snoring(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Change From Baseline in Medical Outcomes Study (MOS) - Sleep Scale: Sleep Shortness of Breath or Headache(From baseline to Week 13 or up to study discontinuation (Study Endpoint))
- Clinical Global Impression of Change(Week 13 or up to discontinuation)
- Patient Global Impression of Change(Week 13 or up to discontinuation)