Status:
COMPLETED
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
Lead Sponsor:
PT Otsuka Indonesia
Conditions:
Dyspepsia
Chronic Gastritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
To study the anti free radical \& inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.
Eligibility Criteria
Inclusion
- Patients who
- are 18 - 80 years old
- have symptoms of dyspepsia that need endoscopic examination
- are suffering from chronic moderate to severe gastritis which is confirmed endoscopically
- are able to give informed concern
Exclusion
- Patients who
- are treated with drugs that induce gastritis/ulcer, such as: NSAID
- are chronic alcoholism,
- are drug abuser
- are contraindicated for endoscopy examination
- has erosive or ulcerative esophagitis
- has peptic ulcer that has been confirmed by endoscopy
- has pyloric stenosis
- has active gastrointestinal bleeding
- has major absorption disorder
- has history of gastric surgery
- with renal disorder (creatinine \> 2 mg/dL)
- with liver disease ( SGOT, SGPT, bilirubin)
- have hematologic disorder ( confirmed with hemoglobin, erythrocytes, leucocytes,differential blood count)
- are suffering from congestive gastropathy due cirrhosis
- are suffering from congestive heart disease
- are pregnant or giving breast feeding
- are hypersensitive to Rebamipide
- are treated with gastroprotective drugs such as : teprenone, sucralfate.
- are treated with acid suppressing medicine (H2A, PPI)
- are treated with antibiotics, mesalazine (Salofalk)
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT00996788
Start Date
October 1 2007
End Date
January 1 2012
Last Update
May 15 2013
Active Locations (1)
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1
Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia
Jakarta, Indonesia