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

May 14, 2013 updated by: PT Otsuka Indonesia
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of Rebamipide 100 mg t.i.d. in reducing gastric mucosal damage due to free radical and inflammation
Time Frame: 2 times (at day-0 and day-28)
2 times (at day-0 and day-28)

Secondary Outcome Measures

Outcome Measure
Time Frame
To confirm the improvement of dyspepsia syndrome
Time Frame: 3 times (at day-0, day-7 and day-28)
3 times (at day-0, day-7 and day-28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

October 15, 2009

First Submitted That Met QC Criteria

October 15, 2009

First Posted (Estimate)

October 16, 2009

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 037-IOB-0701

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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