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Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer

Post-marketing clinical study of rebamipide to determine the healing effect of repeated dosing on gastric ulcer in patients after eradication therapy for Helicobacter pylori (H pylori)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1080220035
Enrollment
300
Registered
2005-09-06
Start date
2004-04-30
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 ulcer

Interventions

Sponsors

Otsuka Pharmaceutical Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are H pylori positive and have active gastric ulcer, and aged 20 yeas or older at time of concent

Exclusion criteria

Exclusion criteria: 1. Patients who have previously received H. pylori eradication therapy 2. Patients with acute gastric ulcer 3. Patients with linear ulcer 4. Patients with complication of duodenal ulcer (excluding cicatrix) 5. Patients who have undergone upper-GI tract or vagal nerve resection 6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis 7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites) 8. Patients with a history of amoxicillin shock 9. Patients with infectious mononucleosis 10. Patients with severe renal disorders 11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide 12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide 13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study 14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator

Design outcomes

Primary

MeasureTime frame
safety efficacy Efficacy/safety

Countries

Japan

Outcome results

None listed

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