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-

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- - Prophylactic efficacy of Proton Pump Inhibitor on Recurrence of Peptic Ulcer in Patients continuously treated with Low-dose Aspirin (CARE Study)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000002901

Enrollment

285

Registered

2009-12-15

Start date

2008-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer

Interventions

Rabeprazole sodium 10mg Tablet, oral administration once a day for 12 weeks. Rabeprazole sodium 20mg Tablet. oral administration once a day for 12 weeks Gefarnate 50mg Capsule oral administration tw

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) patients with ischemic heart failure or vascular disease of brain 2) patients taking low-dose aspirin to prevent relapse of vascular diseases 3) patients who experienced gastric and/or duodenal ulcers before the study by the endoscopy 4) patients without active gastric and duodenal ulcers 5) more than 20 years old 6) outpatients 7) patients written an informed consent

Exclusion criteria

Exclusion criteria: 1) patients with ischemic heart failure, which are acute phase, unstable condition or under 6 months after stent-instillation, 2) patients with brain vascular disease, which are acute phase, unstable condition or under 3 months after the first attack, 3) patients who are uncontrolled and complicated disease, for example thrombocytopenia, and unsuitable for this study as judged by investigator, 4) patients who are uncontrolled renal or liver dysfunction and unsuitable for this study as judged by investigator, 5) patients who are treated with steroid hormones, 6) patients who are women of, pregnant and lactating and childbearing, 7) Patients who are alcoholism, 8) patients who show the hypersensitivity for test drugs, 9) patients who are enrolled in another clinical study, 10) patients who are judged as unsuitable by investigator

Design outcomes

Primary

Measure	Time frame
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers	—

Secondary

Measure	Time frame
Recurrence of gastrointestinal mucosal lesions (Lanza score more than 3), Lanza score and its changes form base line, compliance of low-dose aspirin consumption, the discontinuation rate due to insufficient efficacy of test drugs, mean changes of scores of GSRS, mean changes of scores of F-scale, changes of scores of SF-8, and incidence of adverse events.	—

Countries

Japan

Contacts

Public ContactTsuyoshi Fujita

Kobe University Medical Science in Gastroenterology

gcare@med.kobe-u.ac.jp078-382-6305

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026