NCT01270828已完成3 期
A Phase 3 Double-blind, Randomized, Placebo-controlled, Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia (Protocol A0081224)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.141 个研究点 分布在 1 个国家目标入组 806 人开始时间: 2011年3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
- 806
- 试验地点
- 141
- 主要终点
- Number of Participants With Loss of Therapeutic Response.
研究概览
简要总结
The purpose of the study is to explore the safety and efficacy of a new once a day pregabalin formulation versus placebo for patients with post herpetic neuralgia (Shingles)
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
- •Patients must have pain present for more than 3 months after the healing of the herpes zoster skin rash.
- •At screening (V1) and enrollment (V2), patients must have a score of greater than or equal to 4 on the Pain Numeric Rating Scale (1 week recall period).
- •At enrollment (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be greater than or equal to
- •Male or female of any race, at least 18 years of age, and using appropriate methods of contraception
排除标准
- •Creatinine clearance <30 mL/min (estimated from serum creatinine).
- •Skin conditions in the affected dermatome that could alter sensation
- •Pregabalin use in the last 30 days. Subjects taking pregabalin in the last 30 days should be washed out of pregabalin for at least 30 days prior to screening visit. Patients who had not responded to pregabalin
研究组 & 干预措施
Pregablain CR tablet 82.5 to 660mg
Experimental
干预措施: Pregabalin (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants With Loss of Therapeutic Response.
时间窗: 13 Weeks
Loss of Therapeutic Response (LTR) is defined as \<30% pain response relative to the single blind phase baseline or patient discontinuation due to lack of efficacy or adverse events in the double blind phase of the study. For the calculation of \<30% pain response relative to baseline, baseline will be defined as the mean of the last 7 observations prior to the start of SB treatment, which will be compared with the 7 days rolling average of pain response in DB phase. Participants may be discontinued due to lack of efficacy in this study at the discretion of the study physician.
次要结局
- Change in Mean Daily Sleep Interference Scores(Week 19)
- Participants With Secondary LTR Based on 5 Day Rolling Average Diary Results(13 Weeks)
- Change From Baseline to Endpoint in Weekly Mean Pain Score.(SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19)
- Change in the Weekly NRS-Pain (1-Week Recall).(SB Baseline (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19)
- Number of Participants With Adverse Events(Baseline to Week 20)
- Change in the Medical Outcomes Study-Sleep Scale (MOS-SS).(SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19)
- Percentage of Participants With 30% Reduction in the Mean Pain Score.(13 Weeks)
- Percentage of Participants With 50% Reduction in the Mean Pain Score.(13 Weeks)
- Change in the MOS-SS-Quantity of Sleep.(SB Baseline (BL) (Enrollment) to Week 19 and DB Baseline (Week 6) to Week 19)
- The MOS-SS-Optimal Sleep.(Week 6 and Week 19)
- Percentage of Participants With Change in the Patient Global Impression of Change (PGIC) Score(Week 19)
- Change in Hospital Anxiety and Depression Scales (HADS)(Week 19)
- Percentage of Participants With Benefit From Treatment, Satisfaction With Treatment and Willingness to Continue Treatement (BSW)(Week 19)
- Percentage of Participants With Suicidal Behaviour/Ideation(Baseline, Weeks 6, 11, 15, 19 and 20)
- Change in the Short Form 36 Health Survey (SF-36)(Week 19)
- Change in the Brief Pain Inventory (BPI-sf)(Week 19)
研究者
研究点 (141)
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