NCT01332149已完成3 期
An 11-week Randomized, Double-blind, Multi Center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (300 Mg/Day) Using A Fixed Dosing Schedule In The Treatment Of Subjects S With Pain Associated With Diabetic Peripheral Neuropathy.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.30 个研究点 分布在 1 个国家目标入组 626 人开始时间: 2011年7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
- 626
- 试验地点
- 30
- 主要终点
- Baseline Mean Pain Score
研究概览
简要总结
Pregabalin has proven effective in previous clinical trails in other countries in relieving neuropathic pain associated with postherpetic neuralgia and painful diabetic neuropathy.
This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
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
- •Male and female subjects aged 18 years or older
- •Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
- •At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
- •Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •Women of childbearing potential are willing to use contraception during study.
排除标准
- •Subjects with more than 30% decrease on the Pain Visual Analog Scale at randomization as compared to screening; and during the 1 week screening period, with more than one pain score <3 in pain scores.
- •Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
- •Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
研究组 & 干预措施
300 mg/day pregabalin (Lyrica)
Experimental
Patient take pregabalin capsule twice a day
干预措施: Pregabalin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo matched with pregabalin (Drug)
结局指标
主要结局
Baseline Mean Pain Score
时间窗: Baseline
The daily pain rating scale (DPRS) consists 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 choosing the appropriate number between 0 and 10.
Change From Baseline in Mean Pain Score at Endpoint
时间窗: Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint)
The daily pain rating scale (DPRS) consists 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 choosing the appropriate number between 0 and 10. The mean endpoint pain score was obtained from the last 7 available DPRS scores of the daily pain diary while the participant was on study medication, up to and including the day after the last Week 8 (Day 57) dose.
次要结局
- Percentage of 30 Percent (%) Responders at Endpoint(End of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 9(Baseline and weekly from Weeks 1 to 9)
- Baseline Mean Sleep Interference Score(Baseline)
- Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale(Baseline)
- Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Patient Global Impression of Change (PGIC) Score at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Percentage of Participants Who Had Optimal Sleep at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Clinical Global Impression of Change (CGIC) at Endpoint(Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Sleep Interference Score at Weeks 1 to 9(Baseline and weekly from Weeks 1 to 9)
- Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Baseline Hospital Anxiety and Depression Scale (HADS) Scores(Baseline)
- Change From Baseline in HADS Depression Total Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Mean Sleep Interference Score at Endpoint(Baseline and end of fixed dose phase (Day 63/Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in HADS Anxiety Total Score at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 5, and 9(Baseline; Weeks 1, 5, and 9)
- Change From Baseline in Pain VAS From the SF-MPQ at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Change From Baseline in PPI Scale From the SF-MPQ at Endpoint(Baseline and Day 63 (Week 9)/Early Termination (Study Endpoint))
- Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores(Baseline)
研究者
研究点 (30)
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