Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
NCT ID: NCT00996788
Last Updated: 2013-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
55 participants
INTERVENTIONAL
2007-10-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Rebamipide
Rebamipide 100 mg tid for 28 days
Rebamipide
Rebamipide 100 mg tid for 28 days
Interventions
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Rebamipide
Rebamipide 100 mg tid for 28 days
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
80 Years
ALL
No
Sponsors
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PT Otsuka Indonesia
INDUSTRY
Responsible Party
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Principal Investigators
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Aziz Rani, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Locations
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Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Jakarta, , Indonesia
Countries
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Other Identifiers
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037-IOB-0701
Identifier Type: -
Identifier Source: org_study_id
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