NCT01118572已完成3 期
A Phase III Study of YM177 (Postoperative Pain) -- An Etodolac- and Placebo-controlled, Multicenter, Double-blind, Group Comparison Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients --
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
- 616
- 主要终点
- Patient impressions (4-categorical assessments)
研究概览
简要总结
Aim of the study is to compare efficacy and safety of YM177 with placebo and etodolac in patients with postoperative pain.
详细描述
To verify the superiority to placebo and the noninferiority to etodolac of YM177 in terms of efficacy assessment in patients with postoperative pain. Also, to compare them in terms of safety assessment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with spontaneous pain within 24 hours postoperatively
- •The intensity of the pain:
- •4-categorical assessment: "Moderate pain" or "Severe pain"
- •VAS assessment: 45.0 mm or higher
- •Patients whose postoperative pain can be managed using an oral NSAID
排除标准
- •A past history of aspirin-induced asthma
- •A past of ischemic heart disease, serious arrhythmia, congestive heart failure or cerebrovascular disease
- •Patients who undergoes the surgical procedure under general anesthesia
- •Patients taking excluded medications
研究组 & 干预措施
YM177 group
Experimental
干预措施: YM177 (Drug)
etodolac group
Active Comparator
干预措施: etodolac (Drug)
placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Patient impressions (4-categorical assessments)
时间窗: For 2 days
次要结局
- Pain intensity(For 2 days)
- Pain intensity difference(For 2 days)
- Discontinuation due to insufficient efficacy(For 2 days)
- Safety assessed by AE, clinical lab tests and vital signs(For 2 days)
研究者
相似试验
已完成
2 期
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement SurgeryVenous ThromboembolismNCT00917254Astellas Pharma Inc369
已完成
2 期
Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement SurgeryVenous ThromboembolismNCT00913120Astellas Pharma Inc610
已完成
2 期
A Study of YM178 in Patients With Symptomatic Overactive BladderUrinary Bladder, OveractiveNCT00527033Astellas Pharma Inc842
进行中（未招募）
3 期
A Phase 3 Study to Evaluate the Efficacy of JY09 Compared With Placebo in T2DM PatientsType 2 Diabetes MellitusNCT06254014Beijing Dongfang Biotech Co., Ltd.270
已完成
2 期
Study Evaluating Safety, Tolerability and Efficacy of YM150 in Subjects With Acute Coronary SyndromesAcute Coronary SyndromeNCT00994292Astellas Pharma Europe B.V.1,276