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

Phase 3

• Conditions: Peptic Ulcer

• Registration Number: JPRN-UMIN000002901
• Lead Sponsor: CARE Study Group

Brief Summary

Rabeprazole is superior for reducing the risk of recurrence of peptic ulcer, esophagitis and gastrointestinal symptoms in long-term LDA users with a history of peptic ulcer.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-12-15
• Study Completion: 2010-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 285

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endoscopic Recurrence of Gastric and/or Duodenal Ulcers

Secondary Outcome Measures

Name	Time	Method
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.