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the efficacy and safety of rebamipide to regress gastric atrophy in patients who have undergone the ESD/EMR operation due to early stage gastric cancer or adenoma

open-label, double arm, randomized controlled study, pilot study to evaluate the efficacy and safety of rebamipide to regress gastric atrophy in patients who have undergone the ESD/EMR operation due to early stage gastric cancer or adenoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001915
Enrollment
72
Registered
2016-05-10
Start date
2016-06-23
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

None listed

Sponsors

Kyungpook National University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who have undergone the ESD/EMR due to EGC or adenoma 1. Both men and women aged between 20 and 65 at the time of informed consent 2. Those who have undergone the ESD/EMR due to EGC or adenoma 3. Those who participated in the trial by signing an informed consent form

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to rebamipide 2. Pregnant or breast-feeding women and women of childbearing potential 3. History of mental illness, alcoholism, or drug abuse 4. Concurrent serious heart disease, pulmonary disease or endocrine disorder 5. Participation in another clinical trial within the past 4 weeks 6. History of taking NSAIDs, anticoagulants, prostaglandin E, or steroids within 2 weeks before enrollment 7. Use of other mucosal protective agents which may interfere with the activity of rebamipide 8. Detection during an endoscopy of another gastrointestinal disease requiring treatment (peptic ulcer or other malignant diseases) 9. History of pancreatobiliary disease (excluding asymptomatic cholelithiasis), inflammatory bowel disease, chronic liver disease, or chronic kidney disease 10. Positive UBT at screening after H. pylori eradication 11. Conversion from positive to negative H. pylori test by eradication therapy before screening 12. Subject’s rejection of participation in the trial 13. History of gastrectomy

Design outcomes

Primary

MeasureTime frame
Histological regression of atrophic gastritis: compare regression of atrophic gastritis between the groups—

Secondary

MeasureTime frame
Long-term safety of rebamipide—

Countries

Korea, Republic of

Contacts

Public ContactSeong Woo Jeon

Kyungpook National University Medical Center

sw-jeon@hanmail.net+82-53-200-2602

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 22, 2026