Cardio-cerebrovascular Disease and Aspirin Ulcer Relapse Evaluation

Phase 3

Completed

• Conditions: Cardio-cerebrovascular Disease
• Interventions: Drug: Low-dose PPI (Rabeprazole sodium); Drug: High-dose PPI (Rabeprazole sodium); Drug: Non-PPI (Gefarnate)

• Registration Number: NCT01051388
• Lead Sponsor: Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

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).

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-01
• Last Update Posted: 2011-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Low-dose PPI (Rabeprazole sodium)	Low-dose PPI (Rabeprazole sodium 10 mg)
Group II	High-dose PPI (Rabeprazole sodium)	High-dose PPI (Rabeprazole sodium 20 mg)
Group III	Non-PPI (Gefarnate)	Non-PPI (Gefarnate)

Primary Outcome Measures

Name	Time	Method
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers	12 weeks after giving medication

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Kobe University, School of Medicine; 🇯🇵 Kobe, Hyogo, Japan