NCT01920386已完成3 期
A Randomized, Double-blind, Active-controlled, Parallel, Multicenter Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 主要终点
- SPID ; Sum of the pain intensity differences
研究概览
简要总结
A randomized, double-blind, active-controlled, parallel, multicenter Phase 3 study of Tramadol hydrochloride/Acetaminophen SR Tab. & Tramadol hydrochloride/Acetaminophen Tab. in Acute Toothache Patients above Moderate Pain after Teeth Extraction Surgery.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult males/Females aged over 20 years
- •Patients with over 2 impacted wisdom teeth in the upper and lower jaws
- •Pain VAS Value over 50 mm evaluated as 100mm VAS
- •Subjects who voluntarily or legal guardian agreed with written consent
排除标准
- •Patients with severe heart disease, uncontrol hypertension, diabetes
- •Patients who had taken a long period NSAID (eg. celecoxib, rofecoxib naproxen etc) within 3 days from the screening point
- •Patients who had taken short-time anesthetic drugs and analgesics within 12 hours from the screening point (except short-time anesthetics before or during surgery)
- •Patients with aspirin asthma(asthma seizure caused by NSAIDs) or medical history
- •Patients with severe respiratory depression
研究组 & 干预措施
Tramadol hydrochloride/Acetaminophen Tab.
Active Comparator
1tab PO within 5hours from teeth extraction
干预措施: Tramadol hydrochloride/Acetaminophen Tab. (Drug)
Tramadol hydrochloride/Acetaminophen SR Tab.
Experimental
1tab PO within 5hours from teeth extraction and then 1tab more after 6hours
干预措施: Tramadol hydrochloride/Acetaminophen SR Tab. (Drug)
结局指标
主要结局
SPID ; Sum of the pain intensity differences
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour
次要结局
未报告次要终点
研究者
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