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NCT02423187 Clinical Trial

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

Gastric Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02423187
Other study ID # PRT12T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 17, 2015
Est. completion date October 30, 2017

Study information
Verified date July 2018
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 1568
Est. completion date October 30, 2017
Est. primary completion date October 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions 52 weeks
Secondary Recurrence rate of peptic ulcer 52 weeks
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