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The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritis patients who have undergone endoscopic resection of early gastric cancer

The efficacy of rebamipide on the grade of gastric atrophy and Intestinal metaplasia in gastritis patients who have undergone endoscopic resection of early gastric cancer: multicenter, random ized, double blinded, placebo controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007907
Enrollment
240
Registered
2022-11-17
Start date
2022-11-28
Completion date
Unknown
Last updated
2022-11-28

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

Conditions

None listed

Interventions

Drug : 1. At the time of EMR/ESD: Rapid Urease test/anti-helicobacter IgG Ab/ histology --> If two of them are (+), diagnosis of HP infection could be made. During endoscopy, designated biopsy for the

Sponsors

Kyungpook National University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Gastritis subjects who have undergone the ESD/EMR operation due to early stage gastric cancer 1. Male/Female patients age 20 to 65 at the time of writing an informed consent. 2. Subjects who have consented to participate in this study by signing an informed form.

Exclusion criteria

Exclusion criteria: 1. Patients with known hypersensitivity to Rebamipide formulation. 2. Pregnant, nursing, and childbearing potential women who is unwilling to effective contraception. 3. History of psychological disorder, alcoholics, and drug abuser. 4. History of major medical disease that can affect general condition and other patients deemed not eligible for this study by investigators. 5. Patients who previously underwent another clinical trial within 4 weeks 6. Patients administrated with any drugs that can affect the efficacy of study regimen within 2 weeks, prior to enrolment and/or those who are required of aspirin, NSAIDs, anti-coagulants, prostaglandin E, corticosteroids during the study periods. 7. Patients administrated with any other gastro-protective drugs that can affect the efficacy of Rebamipide during the study period. 8. Other concurrent organic gastric disease in endoscopy(i.e., peptic ulcer disease, other malignancies) 9. History of pancreatobiliary disease (except asymptomatic gallbladder stone), inflammatory bowel disease, cirrhotic liver disease, chronic kidney disease. 10. Patients with negative H. pylori infection as a result of eradication therapy before screening. 11. Patients who failed HP eradication therapy on baseline UBT 12. Patients who have history of gastrectomy for any reason

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study is to evaluate the difference in the effect of between rebamipide and placebo on regression of gastric atrophy and intestinal metaplasia.

Secondary

MeasureTime frame
To evaluate the effect of IP drugs after discontinuation on regression of atrophy and metaplasia. To compare the rate of MGN in more than 4 year follow up period between groups.

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 4, 2026