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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PT Otsuka Indonesia
ClinicalTrials.gov Identifier:
NCT00996788
First received: October 15, 2009
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis

Resource links provided by NLM:

MedlinePlus related topics: Indigestion
U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To confirm the improvement of dyspepsia syndrome [ Time Frame: 3 times (at day-0, day-7 and day-28) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: PT Otsuka Indonesia
ClinicalTrials.gov Identifier: NCT00996788     History of Changes
Other Study ID Numbers: 037-IOB-0701
Study First Received: October 15, 2009
Last Updated: May 14, 2013
Health Authority: Indonesia: National Agency of Drug and Food Control

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
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013