Healthy adult males Healthy adult males
Conditions
Interventions
To investigate the preventive effect of APAP on NSAID-induced gastrointestinal mucosal injury (especially in the small intestine) in healthy adult males. This study will be conducted at the Gastrointe
C06.405.469.275
Sponsors
Nishikawa Hiroki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The study will focus on healthy adults. Recruitment will be open to the general public healthy volunteers who meet all of the following criteria will be included. Japanese healthy adult males between the ages of 20 and 64 on the date consent is obtained. The individual has received a full explanation of the drugs to be used in the study and the purpose and content of the study, has voluntarily volunteered to participate in the study, and has given his/her written consent to participate in the study.
Exclusion criteria
Exclusion criteria: Persons with gastrointestinal symptoms Persons with peptic ulcer, gastrointestinal bleeding, or a history of peptic ulcer or gastrointestinal bleeding Persons with a history of Crohn's disease, intestinal obstruction, or other gastrointestinal diseases Persons with findings or history of suspected colorectal or small intestinal stenosis Persons who have taken any of the following medications within 2 weeks of the start of the observation period NSAIDs (including aspirin), including research drugs Gastric mucous membrane protective drugs (including gastric acid secretion inhibitors) Antibacterial drugs Systemic steroids Persons with underlying medical conditions requiring continuous medication Persons with a history of hypersensitivity to NSAIDs or acetaminophen Persons with a history of aspirin asthma Have a cardiac pacemaker or other electro medical device implanted in the heart Other subjects deemed inappropriate for this study by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of small intestinal mucosal injuries | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Percentage of mucosal injury in the small intestine (frequency of occurrence) 2) Mucosal injury in upper gastrointestinal endoscopy 3) Changes in fecal calprotectin 4) Changes in abdominal symptoms according to the Izumo scale 5) Hemoglobin, transaminase, and creatinine levels 6) Influence of the presence or absence of H. pylori infection on the decrease in the number of mucosal injuries in the upper gastrointestinal tract | — |
Contacts
Public ContactAkitoshi Hakoda
Osaka Medical and Pharmaceutical University Hospital
Outcome results
None listed