NCT01455428已完成4 期
An 8-week Randomized, Double Blind, Multi-center, Placebo-controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin ( 300mg/Day ) Using A Fixed Dosing Schedule In The Treatment Of Subjects With Postherpetic Neuralgia ( Phn )
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 个研究点 分布在 1 个国家目标入组 223 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 22
- 主要终点
- Change From Baseline in Mean Pain Score at Endpoint
研究概览
简要总结
To prove pregabalin is effective in relieving pain compared with placebo in subjects with postherpetic neuralgia (PHN).
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 or female Chinese subjects, ages ≥18 at screening
- •Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
- •At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
- •At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
- •At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days
排除标准
- •Subjects who demonstrate a high response to placebo, with 30% decrease on the Pain Visual Analog Scale (VAS) at randomization as compared to screening
- •Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3
研究组 & 干预措施
Lyrica (pregabalin)
Experimental
干预措施: Lyrica (pregabalin) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Pain Score at Endpoint
时间窗: Baseline until end of fixed dose phase (Day 57/Week 8)/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.
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.
次要结局
- Percentage of 30 Percent (%) Responders at Endpoint(End of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in Short Form McGill Pain Questionnaire (SF-MPQ) Score at Weeks 1, 3, 5, and 8(Baseline; Weeks 1, 3, 5, and 8)
- Baseline Pain Visual Analogue Scale (VAS) and Present Pain Intensity (PPI) Scale(Baseline)
- Change From Baseline in Pain VAS From the SF-MPQ at Endpoint(Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in PPI Scale From the SF-MPQ at Endpoint(Baseline to Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Pain Score at Weeks 1 to 8(Baseline and weekly from Weeks 1 to 8)
- Baseline Mean Sleep Interference Score(Baseline)
- Change From Baseline in Mean Sleep Interference Score at Endpoint(Baseline until end of fixed dose phase (Day 57/Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in Weekly Mean Sleep Interference Scores at Weeks 1 to 8(Baseline and weekly from Weeks 1 to 8)
- Change From Baseline in MOS-Sleep Scale, Snoring Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Awaken Short of Breath Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Quantity of Sleep Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Percentage of Participants Who Had Optimal Sleep at Endpoint(Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Adequacy Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Somnolence Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in MOS-Sleep Scale, Sleep Problems Index Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Baseline Medical Outcomes Study (MOS)-Sleep Scale Scores(Baseline)
- Change From Baseline in MOS-Sleep Scale, Sleep Disturbance Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Clinical Global Impression of Change (CGIC) Score at Endpoint(Day 57 (Week 8)/Early Termination (Study Endpoint))
- Patient Global Impression of Change (PGIC) Score at Endpoint(Day 57 (Week 8)/Early Termination (Study Endpoint))
- Baseline Hospital Anxiety and Depression Scale (HADS) Scores(Baseline)
- Change From Baseline in HADS Anxiety Total Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
- Change From Baseline in HADS Depression Total Score at Endpoint(Baseline and Day 57 (Week 8)/Early Termination (Study Endpoint))
研究者
研究点 (22)
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