Post-Marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00233389
First received: October 4, 2005
Last updated: May 25, 2007
Last verified: May 2007
  Purpose

To examine the efficacy of continued administration of rebamipide following bacteria eradication therapy in patients with H. pylori-positive active gastric ulcer in a placebo-controlled, double-blind study


Condition Intervention Phase
Stomach Ulcer
Drug: Rebamipide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • gastric ulcer healing rate

Estimated Enrollment: 300
Study Start Date: January 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 20 years or older at time of consent
  2. H. pylori-positive patients meeting both of the following criteria:• Assessed as H. pylori-positive by rapid urease test and/or 13C-urea breath test at pre-study examination, • Assessed as H. pylori-antibody-positive by urine-based test after obtaining informed consent
  3. Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification), • Solitary, • Longitudinal diameter: ->5 mm
  4. Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy

Exclusion Criteria:

  1. Patients who have previously received H. pylori eradication therapy
  2. Patients with acute gastric ulcer
  3. Patients with linear ulcer
  4. Patients with complication of duodenal ulcer (excluding cicatrix)
  5. Patients who have undergone upper-GI tract or vagal nerve resection
  6. Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
  7. Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
  8. Patients with a history of amoxicillin shock
  9. Patients with infectious mononucleosis
  10. Patients with severe renal disorders
  11. Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
  12. Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
  13. Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
  14. Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233389

Locations
Japan
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00233389     History of Changes
Other Study ID Numbers: C03700-003, JapicCTI-050035
Study First Received: October 4, 2005
Last Updated: May 25, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Rebamipide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014