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

Phase 3

Completed

• Conditions: Dyspepsia; Chronic Gastritis
• Interventions: Drug: Rebamipide

• Registration Number: NCT00996788
• Lead Sponsor: PT Otsuka Indonesia

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-10-15
• Study First Submitted QC: 2009-10-15
• Study First Posted: 2009-10-16
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-14
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rebamipide	Rebamipide	Rebamipide 100 mg tid for 28 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia; 🇮🇩 Jakarta, Indonesia