A Phase III Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Multiple-Dose Clinical Trial to Study the Efficacy and Safety of MK0663/Etoricoxib 90 and 120 mg, Ibuprofen 600 mg, and Acetaminophen 600 mg/Codeine 60 mg in the Treatment of Patients With Postoperative Dental Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 588
- 主要终点
- Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
研究概览
简要总结
The purpose of this study is to compare the pain relieving effect of different doses of MK0663 with placebo and other pain relievers/analgesics in patients with postoperative dental pain. Pain intensity and relief will be measured by the total pain relief score (TOPAR) and patient evaluation.
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
- •Patients must be scheduled to have 2 or more third molars removed, at least 1 of which is partially embedded in bone and is impacted in the lower jaw
- •Patients must be experiencing moderate to severe pain following the dental procedure
排除标准
- •Previous molar extraction within the past 45 days
- •Personal or family history of an inherited bleeding disorder
- •Uncontrolled high blood pressure
结局指标
主要结局
Total Pain Relief Score Over the First 6 Hours Post the Initial Day 1 Dose of the Study Medication (TOPAR6)
时间窗: Over the first 6 hours post the initial Day 1 dose of the study medication
TOPAR6 was calculated by multiplying the pain relief (PR) score (0- to 4-point Likert scale, with 0=None, and 4=Complete for pain relief) at each time point by the duration (in hours) since the preceding time point, and summing these weighted values up to 6 hours post the initial Day 1 dose. The range of TOPAR6 score is 0 to 24.
次要结局
- Patient's Global Assessment of Study Medication at 24 Hours Post the Initial Day 1 Dose of the Study Medication(At 24 hours post the initial Day 1 dose of the study medication)