Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation (CARE)

April 1, 2011 updated by: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

280

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Kobe University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group I
Low-dose PPI (Rabeprazole sodium 10 mg)
Drug: Low-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
ACTIVE_COMPARATOR: Group II
High-dose PPI (Rabeprazole sodium 20 mg)
Drug: High-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
ACTIVE_COMPARATOR: Group III
Non-PPI (Gefarnate)
Drug: Non-PPI (Gefarnate)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers
Time Frame: 12 weeks after giving medication
12 weeks after giving medication

Secondary Outcome Measures

Outcome Measure
Time Frame
Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events
Time Frame: 12 weeks after giving medication
12 weeks after giving medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Gastro-Intestinal Medical Care Research Center

Investigators

  • Principal Investigator: Takeshi Azuma, M.D., Ph.D., Kobe University, School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

January 15, 2010

First Submitted That Met QC Criteria

January 15, 2010

First Posted (ESTIMATE)

January 18, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 4, 2011

Last Update Submitted That Met QC Criteria

April 1, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRIGID0801
  • UMIN000002901 (OTHER: Japan: Infrastructure for Academic Activities, University hospital Medical Information Network)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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