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)
- Conditions
- SAID-induced small-intestinal injury
- Registration Number
- JPRN-UMIN000007936
- Lead Sponsor
- Division of gastroenterology, Nippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 150
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rate of small intestinal mucosal breaks evaluated by capsule endoscopy after 2-week study treatment
- Secondary Outcome Measures
Name Time Method 1) The mean number of small bowel mucosal breaks per subject 2) Comparison of hemoglobin value and fecal occult blood reaction 3) Incidence rate of adverse events of the digestive system