NCT00662558已完成3 期
A Six Week Double-Blind, Randomized, Multicenter Comparison Study Of The Analgesic Effectiveness Of Celecoxib 200 Mg BID Compared To Tramadol Hydrochloride 50 Mg QID In Subjects With Chronic Low Back Pain
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 802 人开始时间: 2008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
- 802
- 试验地点
- 1
- 主要终点
- Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
研究概览
简要总结
To compare the analgesic effectiveness of celecoxib and tramadol in subjects with Chronic Low Back Pain measured by the Numerical Rating Scale (NRS-Pain) at Week 6
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
- •The subject presents with duration of chronic low back pain of > 3 months requiring regular use of analgesics (> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used
排除标准
- •The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
研究组 & 干预措施
celecoxib
Experimental
干预措施: celecoxib (Drug)
tramadol
Active Comparator
干预措施: tramadol HCL (Drug)
结局指标
主要结局
Treatment Responders Based on the Numerical Rating Scale-Pain (NRS-Pain)
时间窗: Week 6 or Early Termination (ET)
A subject who met the following criteria was considered as a successful responder at Week 6: completed 6 weeks of treatment with study medication and had a 30% improvement from Baseline to Week 6/ET on the NRS-Pain. NRS-Pain scale assessed the severity of a subject's lower back pain on a scale of 0 (No pain) and 10 (Worst possible pain).
次要结局
- Patient's Global Assessment of Disease Activity(Week 6/ET)
- Change From Baseline in Severity of Chronic Low Back Pain as Measured by NRS-Pain(Baseline, Week 6/ET)
- Change From Baseline in Severity of Low Back Pain as Measured by Visual Analogue Scale (VAS)(Baseline, Week 6/ET)
- Patient's Global Evaluation of Study Medication(Weeks 1, 3, and 6/ET)
- Physician's Global Assessment of Disease Activity(Week 6/ET)
- Number of Subjects With Change From Baseline in MOS Optimal Sleep Scale Scores(Baseline, Week 6/ET)
- Change From Baseline in Work Limitations Questionnaire (WLQ)(Baseline, Week 6/ET)
- Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score(Baseline, Week 6/ET)
- Patient's Satisfaction Questionnaire (With Pain Relief Scale)(Week 6/ET)
- Change From Baseline in Modified Brief Pain Inventory (m-BPI-sf)(Baseline, Week 6/ET)
- Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale(Baseline, Week 6/ET)
- Patient's Satisfaction Questionnaire (With Walking and Bending Ability Scale)(Week 6/ET)
- Chronic Low Back Pain Responders Based on VAS, Patient's Global, and RMDQ(Week 6/ET)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Tramadol Versus Celecoxib for Reducing Pain in Outpatient HysteroscopyPainNCT02071303Cairo University210
已完成
2 期
PF-06372865 In Subjects With Chronic Low Back PainChronic Low Back PainNCT02262754Pfizer302
已完成
不适用
Pain Relief in Patients With Chronic Low Back Pain Using HeatTens vs. Standard Care.Chronic Low Back PainMovement Evoked PainNCT03643731Vrije Universiteit Brussel50
已完成
3 期
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)Recurrent Low Back PainNCT00393211Organon and Co319
已完成
3 期
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-041)Recurrent Low Back PainNCT00393354Organon and Co325