NCT00640809已完成4 期
Double-Blind, Placebo-Controlled, Randomized Two-Week Study, Comparing Small Bowel Lesions Associated With Celecoxib (200 mg BID) vs. Ibuprofen (800 mg TID) Plus Omeprazole (20 mg QD)
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 408 人开始时间: 2003年10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
- 408
- 试验地点
- 1
- 主要终点
- Number of mucosal breaks in the small bowel for each subject
研究概览
简要总结
To evaluate the small bowel lesion pattern associated with celecoxib alone versus ibuprofen plus omeprazole
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Normal, healthy gastrointestinal tract (no small bowel mucosal breaks at Day 14 according to endoscopic data
- •No history of GI ulcers, bleeding or surgery, or complete or partial stenosis of the small intestine
- •Willing not to drink any alcohol during study period
排除标准
- •Exclusion criteria:
- •Has established delayed gastric emptying or diabetic gastroparesis
- •Has active gastroesophageal reflux disease or requires anti-ulcer medications
- •Has taken aspirin or nonsteroidal antinflammatory drugs (ibuprofen, naproxen) more than 3 times per week within 2 weeks prior to the screening visit; aspirin for cardiovascular prophylaxis is restricted
研究组 & 干预措施
A
Experimental
干预措施: Celecoxib (Drug)
B
Placebo Comparator
干预措施: Placebo (Other)
C
Active Comparator
干预措施: Ibuprofen plus Omeprazole (Drug)
结局指标
主要结局
Number of mucosal breaks in the small bowel for each subject
时间窗: Day 30
次要结局
- Adverse events(Day 30)
- Laboratory tests(Day 30)
- Vital signs(Day 30)
- Correlation of number of mucosal breaks in the small bowel for each patient with the result of the fecal calprotectin test(Day 30)
- Percentage of subjects with gastric mucosal breaks and the number of mucosal breaks(Day 30)
- Change from screening visit in hemoglobin and hematocrit(Day 30)
- Correlation of the number of gastric mucosal breaks with the number of small bowel mucosal breaks(Day 30)
- Physical examination(Day 30)
- Percentage of subjects with >=1 mucosal breaks(Day 30)
- Total number of small bowel lesions with or without hemorrhage(Day 30)
- Percentage of subjects with visible blood in the small bowel (without visualized lesions in the small bowel)(Day 30)
- Change in Patient General Questionnaire Visual Analog Scale from Day 16(Day 30)
- Change in Severity of Dyspepsia Assessment questionnaire from Day 16(Day 30)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Compare Celecoxib and Ibuprofen Sr In The Management Of Acute Pain Post Orthopedic Or Gynecological SurgeryPain, PostoperativeNCT00150280Pfizer's Upjohn has merged with Mylan to form Viatris Inc.132
已完成
2 期
Effect of celecoxib and ibuprofen versus placebo on pain after laparotomy in drug dependencePain.Unspecified painIRCT201411269014N50Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences114
已完成
4 期
Study Of Celecoxib In Healthy SubjectsHealthy VolunteersNCT00994461Pfizer's Upjohn has merged with Mylan to form Viatris Inc.190
已完成
2 期
Study To Evaluate Efficacy And Safety Of An Additional Dose Of Celecoxib (YM177) In Patients With Post-Tooth Extraction PainPainNCT01062113Pfizer's Upjohn has merged with Mylan to form Viatris Inc.255
已完成
4 期
Study Of Celecoxib Or Diclofenac And Omeprazole For Gastrointestinal (GI) Safety In High GI Risk Patients With ArthritisArthritis, RheumatoidOsteoarthritisNCT00141102Pfizer's Upjohn has merged with Mylan to form Viatris Inc.4,484