Clinical investigation of upper gastrointestinal mucosal injury in patients receiving antiplatelet agents as a single agent or in combination: A randomaized control study in healthy volunteers.

Clinical investigation of upper gastrointestinal mucosal injury in patients receiving antiplatelet agents as a single agent or in combination: A randomaized control study in healthy volunteers. - Upper gastrointestinal mucosal injury by antiplatelet agents

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008311

Enrollment

Registered

2012-07-01

Start date

2012-07-01

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 by antiplatelet agents

Interventions

aspirin (enteric tablet) 100mg/day+ placebo for 2 weeks aspirin (enteric tablet) 100mg/day+ rebamipide 300mg/day for 2 weeks aspirin (enteric tablet) 100mg/day+ clopidogrel 75mg/day+ placebo for 2 wee

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: a. Healthy subjects who have a normal physical examination and laboratory results b.Previous history of peptic ulcer c.Sufficient informed consent is obtained

Exclusion criteria

Exclusion criteria: a. Presence of diseases with a bleeding tendency b. Previous hypersensitivity for ingredient of aspirin c.Severe comorbidities (including malignant tumor, liver cirrhosis, renal failure, and cardiac failure) d. With no regular use of medicine e.Individuals judged by investigators as ineligible for study enrollment.

Design outcomes

Primary

Measure	Time frame
The incidence of upper endoscopic findings (redness, petechia, erosion and ulcer)	—

Secondary

Measure	Time frame
Symptom assessment (using GSRS)	—

Countries

Japan

Contacts

Public ContactKatsuyuki Tozawa

Hyogo College of Medicine Department of lower digestive organs

katu-you@hyo-med.ac.jp0798-45-6662

Outcome results

None listed

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