NCT02423187

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,568

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2017

Completed
Last Updated

August 28, 2018

Status Verified

July 1, 2018

Enrollment Period

2.6 years

First QC Date

April 17, 2015

Last Update Submit

August 27, 2018

Conditions

Gastric UlcerDuodenal Ulcer

Keywords

Stomach ulcerDuodenal ulcerRabeprazoleRecurrence

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reactions

    52 weeks

Secondary Outcomes (1)

  • Recurrence rate of peptic ulcer

    52 weeks

Study Arms (1)

Arm 1

Participants with combination therapy (rabeprazole and low-dose aspirin)

Other: No Intervention

Interventions

No InterventionOTHER
Arm 1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with long-term combination therapy with low-dose aspirin

You may qualify if:

  • 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).
  • Patients with a history of gastric/duodenal ulcers.
  • Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Stomach UlcerDuodenal UlcerRecurrence

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Katsuya Sugizaki

    Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2015

First Posted

April 22, 2015

Study Start

March 17, 2015

Primary Completion

October 30, 2017

Study Completion

October 30, 2017

Last Updated

August 28, 2018

Record last verified: 2018-07

Locations

JP(3)