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Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02423187
Enrollment
1568
Registered
2015-04-22
Start date
2015-03-17
Completion date
2017-10-30
Last updated
2018-08-28

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

Conditions

Duodenal Ulcer, Gastric Ulcer

Keywords

Stomach ulcer, Duodenal ulcer, Rabeprazole, Recurrence

Brief summary

To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.

Interventions

OTHERNo Intervention

Sponsors

Eisai Co., Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole). 2. Patients with a history of gastric/duodenal ulcers. 3. Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

Exclusion criteria

1. Patients with gastric/duodenal ulcers at the start of administration of rabeprazole. 2. Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole. 3. Patients with contraindication for rabeprazole.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse drug reactions52 weeks

Secondary

MeasureTime frame
Recurrence rate of peptic ulcer52 weeks

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026