NCT00894790终止4 期
A Phase IV Open Label Randomized Multicenter Comparative Study Of Celecoxib Efficacy And Safety Versus Standard Doses Of Oral Diclofenac In Acute Pain Due To Cervical Sprain Related To Motor Vehicle Accident
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 8 人开始时间: 2009年11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
- 8
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
研究概览
简要总结
This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident
详细描述
On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.
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
- 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 That Had Suffered A Car Accident And Due To It Suffered A Cervical Sprain
排除标准
- •Recent Cervical Sprains Or Other Cervical Conditions
研究组 & 干预措施
1
Experimental
干预措施: Celecoxib (Drug)
2
Active Comparator
干预措施: oral Diclofenac (Drug)
结局指标
主要结局
Change From Baseline to Day 7 of Participant's Assessment of Cervical Pain Due to Cervical Sprain
时间窗: Baseline, Day 7
Participant rated visual analogue scale (VAS) for pain ranging from 0 to 100 mm (no pain to worst possible pain).
次要结局
- Modified Brief Pain Inventory-Short Form (m-BPI-sf): Pain Severity Index Scores(Baseline, Days 7, 14)
- Change From Baseline in Categorical Responses to Participant's Gastrointestinal (GI) Symptom Questionnaire(Baseline, Days 7, 14)
- Percentage of Participants With at Least a 20 mm Improvement on VAS-pain (Responder Rates)(Baseline, Days 7, 14)
- Change From Baseline in Patient Global Assessment of Cervical Injury(Baseline, Days 7, 14)
- Change From Baseline in Modified Brief Pain Inventory-Short From (m-BPI-sf): Pain Interference Score(Baseline, Days 7, 14)
- Change From Baseline on VAS-pain at Day 3 and Day 14(Baseline, Days 3, 14)
- Change From Baseline on Physician's Global Assessment of Cervical Injury(Baseline, Days 7, 14)
- Change From Baseline in Participant's Responses to Neck Disability Index (NDI)(Baseline, Days 7, 14)
研究者
研究点 (1)
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