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Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

NCT01051388 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2011-04-04

No results posted yet for this study

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.

Conditions

  • Cardio-cerebrovascular Disease

Interventions

DRUG

Low-dose PPI (Rabeprazole sodium)

PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three

DRUG

High-dose PPI (Rabeprazole sodium)

PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)

DRUG

Non-PPI (Gefarnate)

The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

Sponsors & Collaborators

  • Gastro-Intestinal Medical Care Research Center

    collaborator UNKNOWN

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

    lead OTHER

Principal Investigators

  • Takeshi Azuma, M.D., Ph.D. · Kobe University, School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01051388 on ClinicalTrials.gov