Dyspepsia Clinical Trial
Official title:
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Verified date | May 2013 |
Source | PT Otsuka Indonesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: National Agency of Drug and Food Control |
Study type | Interventional |
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
Status | Completed |
Enrollment | 55 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Indonesia | Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia | Jakarta |
Lead Sponsor | Collaborator |
---|---|
PT Otsuka Indonesia |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | No | |
Secondary | To confirm the improvement of dyspepsia syndrome | 3 times (at day-0, day-7 and day-28) | No |
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