Prophylactic Efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients Continuously Treated With Low-dose Aspirin-Randomized, Multi-center, Single-blinded, Parallel-group, Comparative Study

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan1 site in 1 country280 target enrollmentAugust 2008

ConditionsCardio-cerebrovascular Disease

InterventionsLow-dose PPI (Rabeprazole sodium)High-dose PPI (Rabeprazole sodium)Non-PPI (Gefarnate)

DrugsLow-dose PPI (Rabeprazole sodium)High-dose PPI (Rabeprazole sodium)Non-PPI (Gefarnate)

Overview

Phase: Phase 3
Intervention: Low-dose PPI (Rabeprazole sodium)
Conditions: Cardio-cerebrovascular Disease
Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Enrollment: 280
Locations: 1
Primary Endpoint: Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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).

Registry

clinicaltrials.gov

Start Date

August 2008

End Date

December 2010

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Eligibility Criteria

Inclusion Criteria

•patients with ischemic heart failure or vascular disease of brain
•patients taking low-dose aspirin to prevent relapse of vascular diseases
•patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy
•patients without active gastric and duodenal ulcers
•more than 20 years old
•outpatients
•patients written an informed consent

Exclusion Criteria

•patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation
•patients with brain vascular disease , which are acute phase, unstable condition or under 3 months after the first attack
•patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator
•patients who are treated with steroid hormones
•patients who are women of, pregnant and lactating and childbearing
•patients who are alcoholism
•patients who show the hypersensitivity for test drugs
•patients who are enrolled in another clinical study
•patients who are judged as unsuitable by investigator

Arms & Interventions

Group I

Low-dose PPI (Rabeprazole sodium 10 mg)

Intervention: Low-dose PPI (Rabeprazole sodium)

Group II

High-dose PPI (Rabeprazole sodium 20 mg)

Intervention: High-dose PPI (Rabeprazole sodium)

Group III

Non-PPI (Gefarnate)

Intervention: Non-PPI (Gefarnate)

Outcomes

Primary Outcomes

Endoscopic Recurrence of Gastric and/or Duodenal Ulcers

Time Frame: 12 weeks after giving medication

Secondary Outcomes

Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events(12 weeks after giving medication)