The aim of this study is to evaluate the efficacy of proton pump inhibitor (PPI), comparing to the mucosal defensive drug, in the prevention of the recurrence of gastric and/or duodenal ulcers during 12 weeks observation in patients receiving low-dose aspirin for vascular protection.
The events of recurrence of gastric and/or duodenal ulcers will be evaluated due to a blinded manner by specialized endoscopists at pre- and post administration during 12 weeks administration of PPI (Rabeprazole sodium 10 mg or 20 mg tablet once a day) or the mucosal defensive drug (Gefarnate 50mg Capsule twice a day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
280
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)
Kobe University, School of Medicine
Kobe, Hyōgo, Japan
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Time frame: 12 weeks after giving medication
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
Time frame: 12 weeks after giving medication
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