NCT01603394终止4 期
A Phase 4 Multicenter, Open-Label, Pilot Study Of Pregabalin And Prediction Of Treatment Response In Patients With Postherpetic Neuralgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
研究概览
简要总结
The primary objective is to explore whether sensory symptom cluster analysis is useful for predicting treatment response in Postherpetic Neuralgia.
详细描述
The study was stopped on 26 April 2013 due to feasibility issues (low enrollment) not safety. The overall risk-benefit of Lyrica has not changed at all due to termination of this trial. Only 9 of the 150 patients were enrolled into the trial, so we are unable to get adequate results from this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- •At screening (V1) and baseline (V2), subjects must have a score of >=4 on the Numeric Rating Scale for Pain (1 week recall period).
- •At baseline (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be >=4.
排除标准
- •Subjects having other severe pain that may confound assessment or self evaluation of the pain due to PHN.
- •Neurolytic or neurosurgical therapy for Postherpetic Neuralgia
- •Skin conditions in the affected dermatome that could alter sensation.
研究组 & 干预措施
Pregabalin (300-600 mg/day; 150 mg/day starting dose)
Experimental
干预措施: pregabalin (Drug)
结局指标
主要结局
Change From Baseline in the Daily Pain Diary (Numerical Rating Scale, NRS) Mean Pain Score at the End of the Study (Week 6).
时间窗: Baseline, Week 6
The numeric rating scale for pain (NRS-Pain) consists of an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain). A rating of 1-3 is considered mild pain; 4-6, moderate pain; and 7-10, severe pain.
次要结局
- Neuropathic Pain Symptom Inventory (NPSI) at All Visits.(All visits)
- Proportion of Phenotypes Within the 30% and 50% Responder Groups at Baseline and Week 6.(Baseline, Week 6)
- Patient Global Impression of Change (PGIC) at Week 6/Early Termination.(Week 6/Early Termination)
- Proportions of Participants With >/=30% and >/=50% Pain Reduction Based on Daily Pain Diary at Baseline and Week 6.(Baseline, Week 6)
- Proportion of Participants Within Each Phenotype Group as Determined by Sensory Symptom Clustering Using the PainPREDICT, PainDETECT and Neuropathic Pain Symptom Inventory at Baseline and Week 6.(Baseline, Week 6)
- Patient Health Questionnaire-8 (PHQ-8) at Baseline and Week 6; Generalized Anxiety Disorder-7 (GAD-7) at Screening, Visit 2 (Week 0) and Week 6/Early Termination.(Screening, Visit 2 (Week 0) and Week 6/Early Termination)
- Brief Pain Inventory (BPI sf) at Visit 2 (Week 0) and Week 6.(Visit 2 (Week 0), Week 6)
- Patient Catastrophizing Scale (PCS) at Visit 2 (Week 0) and Week 6.(Visit 2 (Week 0), Week 6)
- Pain NRS Score; 1 Week Recall Period.(1 Week)
- Short Form 12v2 Health Survey (SF 12v2) at Visit 2 (Week 0), and Week 6/Early Termination.(Visit 2 (Week 0), and Week 6/Early Termination)
- Change From Baseline to End of the Study (Week 6) in the Daily Sleep Interference Diary (NRS) Mean Pain Score.(Baseline, Week 6)
研究者
研究点 (1)
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