NCT01838044终止4 期
A Randomized Double Blind Placebo Controlled Parallel Group Study Of The Efficacy And Safety Of Concomitant Administration Of Celecoxib And Pregabalin Compared With Celecoxib Monotherapy, In Patients With Chronic Low Back Pain Having A Neuropathic Component
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.29 个研究点 分布在 7 个国家目标入组 180 人开始时间: 2013年10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
- 终止
- 发起方
- 入组人数
- 180
- 试验地点
- 29
- 主要终点
- Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms
研究概览
简要总结
The purpose of this study is to determine if treatment with celecoxib and pregabalin together would prove to be more effective in relief of pain than treatment with celecoxib alone in people who have chronic low back pain with a probable neuropathic component.
详细描述
The primary objective is to evaluate the efficacy of the concomitant use of pregabalin and celecoxib compared with celecoxib monotherapy for the symptomatic relief of pain in patients with chronic low back pain with a probable neuropathic component.
The secondary objectives are:
- Demonstrate the additional benefit of adding pregabalin to celecoxib monotherapy.
- To evaluate the concomitant use of pregabalin and celecoxib compared to celecoxib monotherapy in a set of patient reported measures (sleep, depression, anxiety, impact of pain in daily functions, patient's global impression of change and patient's perception of the treatment).
- To evaluate the safety and tolerability of celecoxib and of the concomitant administration of pregabalin and celecoxib.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have Chronic low back pain with high probability of a significant neuropathic component for 4 years or less (but no less than 3 months)
- •Subjects must be in generally good health, except for the presence of chronic low back pain with a neuropathic component.
- •Subjects must be literate and have the ability (unaided) to understand and use the interactive voice response system (IVRS), have daily access to a telephone or the internet in order to complete the IVRS assessments each day, perform telephone or web visits and complete all required assessments/forms
排除标准
- •Subjects with past history of surgery for chronic low back pain.
- •Subjects with past history of failure on pregabalin treatment and/or intolerance associated with pregabalin or gabapentin.
- •Subjects with past history of intolerance associated with celecoxib or known hypersensitivity to celecoxib.
- •Patients with anticipated need for treatment with opioid analgesics, anti-epileptic medications, SNRI antidepressants or tricyclic antidepressants to alleviate pain during the course of the study.
- •Patients with chronic low back pain with a neuropathic component for more than 4 years.
- •Patients with neurologic disorders unrelated to low back pain that may confuse or confound the assessment of neuropathic pain (eg, primary or secondary nerve diseases).
- •Subjects considered at risk of suicide or self-harm based on investigator judgment and/or details of a risk assessment.
- •Use of prohibited medications in the absence of appropriate washout periods.
- •Patients with any severe pain associated with conditions other than chronic low back pain with a neuropathic component that may confound the assessment or self-evaluation of the pain due to chronic low back pain.
- •Patients with diabetes with poor glycemic control (HbA1c >8%).
- •Patients with any clinically significant or unstable medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, would compromise participation in the study
- •Patients who have participated in any previous clinical trial for pregabalin or have participated in 2 or more previous clinical trials for pain related to chronic low back pain.
- •Patients who are likely to require surgery during the course of the study (except minor surgery, eg, for skin conditions)
- •Patients with a history of Substance Abuse as defined by DSM-IV-TR diagnostic criteria
研究组 & 干预措施
Arm A
Experimental
The group of patients who are randomized to receive concomitant treatment of pregabalin and celecoxib during the first study period.
干预措施: pregabalin and celecoxib (Drug)
Arm B
Other
The group of patients who are randomized to receive celecoxib monotherapy during the first study period.
干预措施: Placebo and celecoxib (Drug)
结局指标
主要结局
Change From Baseline in the Weekly Mean Pain Numeric Rating Scale (NRS) Score at Week 5 (ie, Visit 4) Compared Between the Two Study Arms
时间窗: Baseline and Week 5
The Daily Pain diary consists of an 11-point NRS 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: Select the number that best describes your pain during the past 24 hours from 0 to10 where 0 represents no pain and 10 represents the worst possible pain.
次要结局
- Change in the Weekly Mean Pain NRS Score in Arm B, Compared Between Week 5 (Visit 4) and Week 10 (Visit 6).(Week 5 and Week 10)
- Change From Baseline in the Weekly Mean Pain NRS Score at Week 10 (Visit 6) Compared Between the Two Study Arms(Baseline and Week 10)
- Change From Baseline in Benefit, Satisfaction, and Willingness to Continue Measure Scores Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)(Week 5 and Week 10)
- Patient Global Impression of Change (PGIC) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)(Week 5 and Week 10)
- Percentage of Participants With PGIC for Each Arm Compared at Week 5 (Visit 4) and at Week 10 (Visit 6)(Week 5 and Week 10)
- Change From Baseline in Weekly Mean of Daily Sleep Interference Rating Scale (SIRS) Compared Between Arms at Week 5 (Visit 4) and at Week 10 (Visit 6)(Week 5 and Week 10)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS-A) Anxiety Scores at Week 5 (Visit 4) and Week 10 (Visit 6)(Week 5 and Week 10)
- Change From Baseline in Hospital Anxiety and Depression Scale (HADS-D) Depression Scores at Week 5 (Visit 4) and Week 10 (Visit 6)(Week 5 and Week 10)
- Percentage of Days in Mild, Moderate and Severe Pain at Period 1 and Period 2(Period 1 and Period 2)
- Change From Baseline in Brief Pain Inventory Short Form (BPI sf) - Pain Severity Index Score at Week 5 and Week 10(Week 5 and Week 10)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale - Sleep Disturbance Subscale at Week 5 and Week 10(Week 5 and Week 10)
- Percentage of Participants With >= 30% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10(Week 5 and Week 10)
- Percentage of Participants With >= 50% Reduction From Baseline in the Weekly Mean Pain NRS Score at Week 5 and Week 10(Week 5 and Week 10)
研究者
研究点 (29)
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