NCT00994461已完成4 期
A Randomized, Placebo-Controlled, Double-Blind, Phase 4 Study To Compare The Effect Of Celecoxib 100 Mg BID, Loxoprofen 60 Mg TID And Placebo On The Gastroduodenal Mucosa In Healthy Subjects
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 190 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
- 已完成
- 发起方
- 入组人数
- 190
- 试验地点
- 1
- 主要终点
- Incidence of Gastroduodenal Ulcers
研究概览
简要总结
A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteers
排除标准
- •Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus, stomach, pylorus and/or duodenum prior to treatment endoscopy
- •A history of gastrointestinal ulcer
- •Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin), anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication
研究组 & 干预措施
Celecoxib
Experimental
干预措施: Celecoxib (Drug)
Loxoprofen
Active Comparator
干预措施: Loxoprofen (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Gastroduodenal Ulcers
时间窗: 2 weeks
The percentage of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment (The number of subjects who had gastroduodenal endoscopic ulcers after 2 weeks treatment divided by participants multiplied by 100.) An ulcer is defined as any break in the mucosa at least 3 mm in diameter with unequivocal depth.
次要结局
- Incidence of Any Gastric, and Duodenal Ulcers(2 weeks)
- Incidence of Any Gastroduodenal, Gastric, and Duodenal Ulcers and/or Erosions(2 weeks)
- Post-treatment Gastroduodenal Endoscopic Scores (According to Mucosal Grading Scale)(2 weeks)
- Number of Gastroduodenal Ulcers in Each Subject(2 weeks)
- Number of Gastroduodenal Erosions in Each Subject(2 weeks)
- Incidence of Treatment-emergent, All-causality GI Body System Adverse Events(2 weeks)
研究者
研究点 (1)
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