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

• Status: Completed
• Trial end date: 2005-09-09
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Rebamipide

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