The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD -multicenter randomized controlled study of irsogladine + PPI versus PPI alone-

The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD -multicenter randomized controlled study of irsogladine + PPI versus PPI alone- - The study on the preventive effect of irsogladine for gastric bleeding risk of antithrombotic drugs after ESD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012434

Enrollment

200

Registered

2013-11-28

Start date

2013-12-01

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

gastric tumor(early gastric cancer, gastric adenoma)

Interventions

rabeprazole 10mg/day p.o. for 8 weeks rabeprazole 10mg/day and irsogladine 4mg/day p.o. for 8 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with gastric tumor who are aged 20 years or older when the written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1)Subjects with hematemesis, melena or anemia lack of hemoglobin 2 g/dL or more during the observation period 2)Subjects with significant hepatic disease, renal disease, heart disease or respiratory disease 3)Subjects with a history of gastrointestinal surgery other than appendectomy 4)Subjects orally taking or planning to orally take drug other than rabeprazole or irsogladine 5)Pregnancy or lactation 6)Subjects whom otherwise the investigator determined ineligible as the subject

Design outcomes

Primary

Measure	Time frame
Frequency of gastrointestinal bleeding after ESD	—

Countries

Japan

Contacts

Public ContactToshihisa Takeuchi

Osaka Medical College Hospital Endoscopic Center

in2097@poh.osaka-med.ac.jp072-683-1221

Outcome results

None listed

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