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

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PT Otsuka Indonesia
• Treatments: Anti-Inflammatory Agents; Rebamipide

Criteria

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)