NCT01298466撤回4 期
Open-Labeled European Study To Support The Early Identification Of Patients With Chronic Neuropathic Low Back Pain In Primary Care And To Assess The Effectiveness And Tolerability Of Pregabalin In This Population
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.0 个研究点开始时间: 2012年2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
- 撤回
- 发起方
- 主要终点
- The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
研究概览
简要总结
A0081256 is a prospective, open-label, multi-centre European study designed to raise awareness and enhance the diagnosis of patients with chronic low back pain with a neuropathic pain component in primary care who are refractory to standard analgesic therapy and/or one treatment for neuropathic pain and evaluate the effectiveness and tolerability of pregabalin in this population. The impact of pregabalin on analgesia, patient satisfaction with treatment, patient anxiety and depression, sleep interference, physical functioning and work productivity will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Patients must have low back pain with a neuropathic pain component between 3 months and 12 months duration prior to entering the study.
- •Patients must have a score of at least 19 on the PainDetect questionnaire and at least 4 on the Standardized Evaluation of Pain (StEP) scale at screening.
- •Patients must have a mean pain numerical rating scale (NRS) score of 4 or more during the one week screening period.
- •Patients must have failed to respond to standard analgesic therapy (e.g. non-steroidal anti-inflammatory drugs [NSAIDs]) and/or one treatment for neuropathic pain (e.g. tricyclics, serotonin-norepinephrine re-uptake inhibitors [SNRIs]) prior to entering the study).
排除标准
- •A diagnosis of depression or a Hospital Anxiety and Depression Scale (HADS) score of > 15 on the depression sub-scale only.
- •Patients with a history of renal impairment or who have reduced renal function at baseline (Creatinine Clearance < 60 mL/min).
- •Patients who have previously taken pregabalin or gabapentin within 6 months prior to entering the study.
- •Patients who have undergone previous surgery for back pain.
- •Patients who are using high doses of opioid medication (morphine > 60 mg per day).
研究组 & 干预措施
Pregabalin
Experimental
Open label study. All patients fulfilling the protocol inclusion/exclusion criteria will receive pregabalin in a flexible-dosing regimen.
干预措施: Pregabalin (Drug)
结局指标
主要结局
The Patients' Global Impression of Change (PGIC) score at the end of the study (Week 12).
时间窗: 12 weeks
The change in the daily pain diary (Numerical Rating Scale, NRS) mean pain score at the end of the study (Week 12) compared with baseline.
时间窗: 12 weeks
次要结局
- The change in the Lost Work Day Equivalent (LWDE) score at the end of the study (Week 12) compared with baseline.(12 weeks)
- The proportion of patients with a 50% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).(12 weeks)
- The percentage of primary care physicians who find screening tools useful instruments to support the identification of patients with neuropathic chronic low back pain in daily practice.(12 weeks)
- The time to onset of 30% pain reduction (as measured by the NRS mean pain score).(12 weeks)
- The change in the Hospital Anxiety and Depression Scale (HADS) score at the end of the study (Week 12) compared with baseline.(12 weeks)
- The change in the Roland-Morris Disability Questionnaire (RMDQ) score at the end of the study (Week 12) compared with baseline.(12 weeks)
- The proportion of patients with a 30% reduction in pain from baseline at study endpoint (as measured by the NRS mean pain score).(12 weeks)
- The nature and incidence of adverse events for patients taking 150 mg pregabalin at night as a single dose, either for one week prior to dose escalation or as continued after the option to escalate dose following one week in the study.(12 weeks)
- The change in the Sleep Interference Scale score at the end of the study (Week 12) compared with baseline.(12 weeks)
- The change in the PainDetect score from baseline versus the change in the Standardized Evaluation of Pain (StEP) score from baseline at the end of the study (Week 12).(12 weeks)
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