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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00996788
First Posted: October 16, 2009
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
PT Otsuka Indonesia
  Purpose
To study the anti free radical & inflammatory effect and safety of Rebamipide in patients suffering of dyspepsia due to chronic gastritis.

Condition Intervention Phase
Dyspepsia Chronic Gastritis Drug: Rebamipide Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by PT Otsuka Indonesia:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • To confirm the improvement of dyspepsia syndrome [ Time Frame: 3 times (at day-0, day-7 and day-28) ]

Enrollment: 55
Study Start Date: October 2007
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rebamipide
Rebamipide 100 mg tid for 28 days
Drug: Rebamipide
Rebamipide 100 mg tid for 28 days

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996788


Locations
Indonesia
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
  More Information

Responsible Party: PT Otsuka Indonesia
ClinicalTrials.gov Identifier: NCT00996788     History of Changes
Other Study ID Numbers: 037-IOB-0701
First Submitted: October 15, 2009
First Posted: October 16, 2009
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by PT Otsuka Indonesia:
Patients suffering of dyspepsia due to chronic gastritis

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Gastritis, Atrophic
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors


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