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

Dyspepsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00996788
• Other study ID #: 037-IOB-0701
• Status: Completed
• Phase: Phase 3
• First received: October 15, 2009
• Last updated: May 14, 2013
• Start date: October 2007
• Est. completion date: January 2012

Study information

• 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

Clinical Trial Summary

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

Recruitment information / eligibility

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Gastritis
• Dyspepsia
• Gastritis

Intervention

Drug:
• Rebamipide
Rebamipide 100 mg tid for 28 days

Locations

Country	Name	City	State
Indonesia	Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
PT Otsuka Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

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