NCT00649610已完成4 期
Randomized, Double Blind, Multicenter Study of the Safety and Efficacy of Valdecoxib 40 mg Once Daily vs. Diclofenac 75 mg Twice Daily in Subjects With Acute Low Back Pain
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 340
- 试验地点
- 1
- 主要终点
- Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
研究概览
简要总结
The pain relief, safety, and tolerability of valdecoxib 40 mg once daily compared with diclofenac 75 mg twice daily for acute low back pain was studied. The effect of valdecoxib on the patient's level of disability and quality of life was also studied.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute low back pain, defined as either class 1a or class 2a according to the Quebec Task Force Classification and categorized as moderate-severe in the Pain Intensity Categorical Scale and Visual analogue score (VAS) greater or equal to 50 mm
- •Acute low back pain was to have started at least 72 hours prior to inclusion in the trial and more than 6 weeks after the last episode of acute low back pain
- •History of at least 1 reported episode of acute low back pain in the last 5 years
排除标准
- •History of inflammatory arthritis, chronic pain, metastasis, Paget's disease, or other diseases known to cause pain
- •Moderate to severe scoliosis
- •Back pain due to major trauma or visceral disorder
- •Unwilling to refrain from commencing concomitant physiotherapy
- •Active or suspected esophageal, gastric pyloric channel, or duodenal ulceration or bleeding within 30 days prior to the first dose of study medication
- •Any known laboratory abnormality, which in the opinion of the investigator, would contraindicate study participation
- •Subject was pregnant or lactating woman , or was a woman of childbearing potential not using an acceptable method of contraception
研究组 & 干预措施
Arm 1
Active Comparator
干预措施: valdecoxib (Drug)
Arm 2
Active Comparator
干预措施: diclofenac (Drug)
结局指标
主要结局
Subject-rated VAS Pain Intensity (0 - 100 mm), which was evaluated using the change from baseline
时间窗: Day 3
次要结局
- Pain Relief(Day 3 and Day 7)
- Patient global evaluation(Day 3 and Day 7)
- Subject's functional capacity as measured by the Oswestry Low Back Pain and Disability Questionnaire(Day 7)
- Subject's quality of life as measured by the Acute short form (SF)-36 (8 domains)(Day 7)
- Composite Upper Gastrointestinal (UGI) Tolerability was calcluated. A subject had a UGI event if the subject reported at least 1 of the following: moderate or severe nausea, or moderate or severe abdominal pain, or moderate or severe dyspepsia(Day 7)
- VAS Pain Intensity (0-100 mm)(Day 7)
- Categorical Pain Intensity(Day 3 and Day 7)
研究者
研究点 (1)
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