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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00996788
Other study ID # 037-IOB-0701
Secondary ID
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


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
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