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

NCT ID: NCT00996788

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dyspepsia Chronic Gastritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rebamipide

Rebamipide 100 mg tid for 28 days

Group Type EXPERIMENTAL

Rebamipide

Intervention Type DRUG

Rebamipide 100 mg tid for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rebamipide

Rebamipide 100 mg tid for 28 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PT Otsuka Indonesia

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Aziz Rani, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Gastroenterology Department of Internal Medicine - Cipto Mangunkusumo Hospital, Faculty of Medicine University of Indonesia

Jakarta, , Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

037-IOB-0701

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.