NSAID-induced small-intestinal injury
Conditions
Interventions
Subjects in celecoxib group are administrated celecoxib 100 mg twice per day for 2 weeks
Subjects in loxoprofen + lansoprazole group are administrated loxoprofen 60 mg three times per day plus lansopr
Sponsors
Division of gastroenterology, Nippon Medical School
Sumida Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy male and female adult Japanese volunteer 2) If the subject is female of childbearing potential, she must have been non-pregnant (negative pregnancy test at screening), non-lactating and using adequate contraception during the study 3) Clinical laboratory test results must have been normal or non-clinically significant at Pretreatment 4) Written informed consent must have been obtained
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of small intestinal mucosal breaks evaluated by capsule endoscopy after 2-week study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactShunji Fujimori
Nippon Medical School Department of Internal Medicine, Division of Gastroenterology
Outcome results
None listed