Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

Cardio-cerebrovascular Disease Clinical Trial

— CARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051388
• Other study ID #: TRIGID0801
• Secondary ID: UMIN000002901
• Status: Completed
• Phase: Phase 3
• First received: January 15, 2010
• Last updated: April 1, 2011
• Start date: August 2008
• Est. completion date: December 2010

Study information

• Verified date: April 2011
• Source: Translational Research Informatics Center, Kobe, Hyogo, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardio-cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Drug:
• Low-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 10 mg), once a day, for four weeks times three
• High-dose PPI (Rabeprazole sodium)
PPI (Rabeprazole sodium 20 mg Tablet once a day, for four weeks times three)
• Non-PPI (Gefarnate)
The mucosal defensive drug (Gefarnate 50 mg Capsule, twice a day, for four weeks times three)

Locations

Country	Name	City	State
Japan	Kobe University, School of Medicine	Kobe	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Translational Research Informatics Center, Kobe, Hyogo, Japan	Gastro-Intestinal Medical Care Research Center

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic Recurrence of Gastric and/or Duodenal Ulcers		12 weeks after giving medication	Yes
Secondary	Recurrence of gastrointestinal mucosal lesions, Lanza score and its changes form baseline, and incidences of adverse events		12 weeks after giving medication	Yes

External Links

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