JPRN-UMIN000007936已完成未知
Effects of 2-week celecoxib treatment on the small intestinal mucosa in Japanese healthy subjects evaluated by capsule endoscopy (A prospective, randomized, double-blind, parallel-group, controlled study compared to the combination of loxoprofen sodium and lansoprazole) - Capsule endoscopy: Celecoxib vs Loxoprofen/ Lansoprazole
Division of gastroenterology, Nippon Medical School0 个研究点目标入组 150 人开始时间: 2012年5月13日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 40years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Positive in fecal occult blood test. Suspected gastrointestinal tract disturbance based on clinical safety laboratory tests and physical examination at screening 2) A possibility to effect on absorption of drugs (gastrectomy etc.) 3) A history of gastrointestinal ulcer 4) A history of gastrointestinal disease within 1 month or current gastrointestinal complaints at the time of admission to the study 5) Any use of celecoxib, nonsteroidal anti-inflammatory drugs, anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks prior to the first dose of study medication. 6) A history of medically significant disease, including ischemic heart disease 7) Subject has a serious hematological abnormality or serious cardiac failure 8) Subject has an active malignancy or history of a malignancy within 5 years prior to enrollment in study. 9) A history of chronic ingestion of more than 2 alcoholic drinks per day (1 drink: wine 150 mL, beer 360 mL or spirit 45 mL) 10) Clinically significant abnormalities in 12-lead ECG 11)Hypersensitivity to celecoxib, sulfonamides, aspirin, NSAIDs, or lansoprazole 12) A history of aspirin- or NSAIDs-induced asthma 13)Laboratory screening >1.5 ULN for AST, ALT, serum creatinine more than 1.1 mg/dL or other clinically significant lab abnormalities at screening 14) Positive in HBs antigen tests, HIV test, HCV test and syphilis test at screening 15) Positive in urine drug test at screening 16) Judged to be inappropriate due to psychiatric disorders 17) Received any investigational drug within 30 days 18) Other serious acute/chronic medical/psychological condition, and other laboratory abnormalities that may be worsened by the trial or test drug administration, or that may affect the trial endpoints 19) Any other subjects judged to be inappropriate to participate in the study by the investigator
研究者
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