NCT00407745已完成3 期
A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2007年1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
- 220
- 试验地点
- 1
- 主要终点
- Duration Adjusted Average Change (DAAC) of Mean Pain Score
研究概览
简要总结
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
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
- •Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
- •Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
- •Pain score at least 4 in 4 of 7 days prior to receive treatment.
排除标准
- •Pregabalin use in the last 60 days, prior intolerance to pregabalin
- •Creatinine clearance <60 mL/min.
- •White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm
- •Abuse of drugs or alcohol
- •Unstable medial conditions
- •Clinically significant abnormal electrocardiogram (ECG).
- •Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
研究组 & 干预措施
matched placebo
Placebo Comparator
干预措施: placebo (Drug)
pregabalin
Experimental
flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
干预措施: pregabalin (Drug)
结局指标
主要结局
Duration Adjusted Average Change (DAAC) of Mean Pain Score
时间窗: Baseline, Week 16
DAAC was derived from participant's daily pain diary, where pain was measured on an 11-point Numerical Rating Scale (NRS-Pain)ranging from 0 (did not interfere with sleep) to 10 (completely interfered \[unable to sleep due to pain\]). The DAAC was calculated as the mean of all daily pain diary rating post baseline minus the baseline score then multiplied by the proportion of the planned study duration completed by the participant.
次要结局
- Change From Baseline in Weekly Mean Pain Score(Baseline, Week 16)
- Number of Participants With >=30% Reduction in Weekly Mean Pain Score From Baseline(Baseline, Week 16)
- Number of Participants With Categorical Scores on the Patient Global Impression of Change (PGIC) (Full Scale)(Baseline, Week 16)
- Change From Baseline in Weekly Mean Sleep Interference Score(Baseline, Week 16)
- Change From Baseline in Weekly Mean Pain Score by Week(Baseline, Week 1 through16)
- Number of Participants With >=50% Reduction in Weekly Mean Pain Score From Baseline(Baseline, Week 16)
- Change From Baseline in Modified Brief Pain Inventory Interference Scale (10-Item) (mBPI-10) Total Score(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Static Mechanical Allodynia(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP) - Dynamic Mechanical Allodynia(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Punctata Hyperalgesia(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Temporal Summation to Tactile Stimuli(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Allodynia(Baseline, Week 16)
- Change From Baseline in Quantitative Assessment of Neuropathic Pain (QANeP)- Cold Hyperalgesia Subscales(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - 12 Items Total Intensity Score(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Burning Spontaneous Pain(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Pressing Spontaneous Pain(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paroxysmal Pain(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Evoked Pain(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Paresthesia/Dysesthesia(Baseline, Week 16)
- Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) - Individual Item (1, 2, 3, 5, 6, 8, 9, 10, 11, 12) Score(Baseline, Week 16)
- Number of Participants With Improved Duration of Brief Pain Attacks Based on NPSI - Duration (Item 4)(Baseline, Week 16)
- Number of Participants With Improvement in the Number of Attacks Based on NPSI - Number of Attacks (Item 7)(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS)- 9-Item Overall Sleep Problems Index(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Disturbance(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Adequacy(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Snoring(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Awaken Short of Breath or With a Headache(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Sleep Quantity(Baseline, Week 16)
- Change From Baseline in Medical Outcomes Study Sleep Scale (MOS-SS) - Somnolence(Baseline, Week 16)
- Number of Participants Having Optimal Sleep Based on Medical Outcomes Study Sleep Scale (MOS-SS)(Baseline, Week 16)
- Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Anxiety(Baseline, Week 16)
- Change From Baseline in Hospital and Anxiety Depression Scale (HADS) - Depression(Baseline, Week 16)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Pregabalin in the Treatment of Pain Due to Diabetic Peripheral NeuropathyDiabetic Neuropathy, PainfulNCT00159679Pfizer's Upjohn has merged with Mylan to form Viatris Inc.167
已完成
3 期
Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic PainNeuropathic PainNCT01701362Pfizer's Upjohn has merged with Mylan to form Viatris Inc.542
已完成
3 期
A Controlled Pregabalin Trial In FibromyalgiaFibromyalgiaNCT00230776Pfizer's Upjohn has merged with Mylan to form Viatris Inc.740
已完成
3 期
Study of Pregabalin Versus Placebo in the Treatment of Nerve Pain Associated With HIV NeuropathyHIV InfectionsPeripheral NeuropathyNCT00232141Pfizer's Upjohn has merged with Mylan to form Viatris Inc.302
已完成
4 期
Study of Pregabalin Therapy for Pain Relief in Subjects With Post-Herpetic NeuralgiaPost-Herpetic NeuralgiaNCT00159666Pfizer's Upjohn has merged with Mylan to form Viatris Inc.255