Status:
COMPLETED
Post-marketing Clinical Study of Rebamipide in Patients With Gastric Ulcer
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Stomach Ulcer
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Patients aged 20 years or older at time of consent
- 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
- Patients endoscopically diagnosed with gastric ulcer meeting the following criteria:• Active (A1- or A2-stage by Sakita/Miwa classification）, • Solitary, • Longitudinal diameter: -\>5 mm
- Patients who have not received proton pump inhibitors (PPIs), antibacterial agents, or antiprotozoal agents within 1 week prior to endoscopy
Exclusion
- Patients who have previously received H. pylori eradication therapy
- Patients with acute gastric ulcer
- Patients with linear ulcer
- Patients with complication of duodenal ulcer (excluding cicatrix)
- Patients who have undergone upper-GI tract or vagal nerve resection
- Patients who are unsuitable for pharmacotherapy, e.g., with perforation or pyloric stenosis
- Patients with gastric ulcer considered likely to induce massive hemorrhage (e.g., with obviously exposed blood vessels at lesion sites)
- Patients with a history of amoxicillin shock
- Patients with infectious mononucleosis
- Patients with severe renal disorders
- Patients with a history of hypersensitivity to penicillins, clarithromycin, lansoprazole, or rebamipide
- Patients who have been treated with drugs contraindicated to clarithromycin, such as terfenadine, cisapride, and pimozide
- Patients who are pregnant, possibly pregnant, lactating, or who desire to become pregnant during the study
- Patients who are otherwise judged inappropriate for inclusion in the study by the investigator or subinvestigator
Key Trial Info
Start Date :
April 30 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2005
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00233389
Start Date
April 30 2004
End Date
September 9 2005
Last Update
June 4 2021
Active Locations (1)
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1
Otsuka Pharmaceutical Co., Ltd.
Tokyo, Japan