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

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. Identifier: NCT00233389
Recruitment Status : Completed
First Posted : October 5, 2005
Last Update Posted : May 28, 2007
Information provided by:
Otsuka Pharmaceutical Co., Ltd.

October 4, 2005
October 5, 2005
May 28, 2007
January 2004
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gastric ulcer healing rate
Same as current
Complete list of historical versions of study NCT00233389 on Archive Site
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Post-Marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
A Post-Marketing Clinical Study of Rebamipide to Investigate the Gastric Ulcer Healing Effect of Continued Dosing Following Helicobacter Pylori Eradication Therapy
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
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Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Stomach Ulcer
Drug: Rebamipide
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
September 2005
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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
Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Otsuka Pharmaceutical Co., Ltd.
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Study Director: Katsuhisa Saito Division of New Product Evaluation and Development
Otsuka Pharmaceutical Co., Ltd.
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP