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

• Sponsor: PT Otsuka Indonesia (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00996788
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Duration (Months): 51
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dyspepsia; Chronic Gastritis	Drug: Rebamipide	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rebamipide Rebamipide 100 mg tid for 28 days	Drug: Rebamipide; Rebamipide 100 mg tid for 28 days

Outcome Measures

Primary Outcome Measures

1. 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

1. To confirm the improvement of dyspepsia syndrome [3 times (at day-0, day-7 and day-28)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia	Jakarta		Indonesia

Sponsors and Collaborators

• PT Otsuka Indonesia

Investigators

• Principal Investigator: Aziz Rani, MD, Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PT Otsuka Indonesia
• ClinicalTrials.gov Identifier: NCT00996788
• Other Study ID Numbers: 037-IOB-0701
• First Posted: Oct 16, 2009
• Last Update Posted: May 15, 2013
• Last Verified: May 1, 2013

• Keywords provided by PT Otsuka Indonesia: Patients suffering of dyspepsia due to chronic gastritis
• Additional relevant MeSH terms: Gastritis; Gastritis, Atrophic; Dyspepsia; Rebamipide

Study Results

No Results Posted as of May 15, 2013