Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00996788

Enrollment

Registered

2009-10-16

Start date

2007-10-31

Completion date

2012-01-31

Last updated

2013-05-15

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

Conditions

Chronic Gastritis, Dyspepsia

Keywords

Patients suffering of dyspepsia due to chronic gastritis

Brief summary

To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.

Interventions

DRUGRebamipide

Rebamipide 100 mg tid for 28 days

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Patients who 1. are 18 - 80 years old 2. have symptoms of dyspepsia that need endoscopic examination 3. are suffering from chronic moderate to severe gastritis which is confirmed endoscopically 4. are able to give informed concern

Exclusion criteria

Patients who 1. are treated with drugs that induce gastritis/ulcer, such as: NSAID 2. are chronic alcoholism, 3. are drug abuser 4. are contraindicated for endoscopy examination 5. has erosive or ulcerative esophagitis 6. has peptic ulcer that has been confirmed by endoscopy 7. has pyloric stenosis 8. has active gastrointestinal bleeding 9. has major absorption disorder 10. has history of gastric surgery 11. with renal disorder (creatinine \> 2 mg/dL) 12. with liver disease ( SGOT, SGPT, bilirubin) 13. have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count) 14. are suffering from congestive gastropathy due cirrhosis 15. are suffering from congestive heart disease 16. are pregnant or giving breast feeding 17. are hypersensitive to Rebamipide 18. are treated with gastroprotective drugs such as : teprenone, sucralfate. 19. are treated with acid suppressing medicine (H2A, PPI) 20. are treated with antibiotics, mesalazine (Salofalk)

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation	2 times (at day-0 and day-28)

Secondary

Measure	Time frame
To confirm the improvement of dyspepsia syndrome	3 times (at day-0, day-7 and day-28)

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026