NCT01062113已完成2 期
A Randomized, Double-Blind, Multicenter, Comparative Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In The Treatment Of Acute Pain After Oral Surgery Lateral Mandibular Impacted Third Molar Tooth Extraction
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.22 个研究点 分布在 1 个国家目标入组 255 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 255
- 试验地点
- 22
- 主要终点
- Efficacy Rate (Percentage) of Patient's Impression
研究概览
简要总结
To evaluate efficacy and safety of additional dose of celecoxib, as compared to placebo, in patients with post lateral mandibular impacted third molar tooth extraction pain.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Initial dose:
- •20 to 64 years
- •Patients with undergoing mandibular impacted third molar tooth extraction accompanied by lateral bone removal and crown cutting
- •Patients with pain that meets both of the following criteria
- •Pain intensity (4-categorical): "moderate pain" or "severe pain"
- •Pain intensity (VAS): 45.0 mm or more
- •Additional dose:
- •Patients with pain that corresponds to "
- •Agree" or "
- •Strongly agree" as the answer to the "question about the pain intensity" during the period from 5 hours to 12 hours post-initial dose of the study drug
排除标准
- •Patients with acute inflammatory findings in the oral cavity necessitating treatment
- •Patients who are scheduled to receive general anesthesia and analgesics in the process of the eligible tooth extraction
研究组 & 干预措施
Celecoxib 400mg
Experimental
干预措施: Celecoxib (Drug)
Celecoxib 200mg
Experimental
干预措施: Celecoxib (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy Rate (Percentage) of Patient's Impression
时间窗: 2 hours post-additional dose
Patient's impression was assessed by self-report and was entered in the patient diary, based on the following categories: "Excellent", " Good", "Fair" and "Poor". Efficacy rate was calculated from the following formula, "The number of participants assessed as Excellent or Good" over "total participants" multiplied by 100.
次要结局
- Differences in Pain Intensity (PI) Measured by VAS Among Participants(Pre-additional dose (baseline) and 2 hours post-additional dose)
- Number of Participants in Each Pain Intensity (PI) With 4 Categories(2 hours after additional dose)
- Pain Intensity Measured by Visual Analog Scale (VAS)(2 hours post-additional dose)
研究者
研究点 (22)
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