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Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers

Clinical trial on the incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin: a randamized control study using transnasal endoscopy in healthy volunteers - Incidence of upper gastrointestinal mucosal injury induced by low-dose aspirin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001375
Enrollment
40
Registered
2008-09-14
Start date
2008-09-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

upper gastrointestinal mucosal injury

Interventions

three kinds of placeboes for 7 days Enteric-coated aspirin 100 mg/day + two kinds of placeboes for 7 days Enteric-coated aspirin 100 mg/day + rebamipide 300mg/day + placebo for 7 days Enteric-coate

Sponsors

Endoscopy Center, Tokyo Medical University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: a. Healthy subjects who have a normal physical examination and laboratory results b. Obtaining informed consent c. H.pylori negative

Exclusion criteria

Exclusion criteria: a. hemorrhage tendency b. hypersensitivity for element of aspirin c. previous history of aspirin induced asthma d. previous history of peptic ulcer e. severe blood disease f. severe complication (malignant tumor, liver cirrhosis, renal failure, cardiac failure, etc) g. pregnant woman,or possibility of pregnancy h. smoker i. Inadequate to entry judged by investigators

Design outcomes

Primary

MeasureTime frame
The number of transnasal endoscopic findings (red spots, petechiae, erosion, ulcer)

Secondary

MeasureTime frame
Symptom assessment (using GSRS)

Countries

Japan

Contacts

Public ContactTakashi Kawai

Tokyo Medical University Hospital Endoscopy Center

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026