Rabeprazole Specific Clinical Experience Investigation fo... | NCT02423187

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

NCT02423187

Sponsor

Eisai Co., Ltd.

Status

Completed

Last Update Posted

Aug 28, 2018Actual

Enrollment

1,568Actual

Phase

Not provided

Conditions

Gastric Ulcer
Duodenal Ulcer

Interventions

No Intervention

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2015Actual

Primary Completion Date

Oct 30, 2017Actual

Completion Date

Oct 30, 2017Actual

First Submitted Date

Apr 17, 2015

First Submission Date that Met QC Criteria

Apr 17, 2015

First Posted Date

Apr 22, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2018

Last Update Posted Date

Aug 28, 2018Actual

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,568Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1		Participants with combination therapy (rabeprazole and low-dose aspirin)	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other		Arm 1

Measure	Description	Time Frame
Incidence of adverse drug reactions		52 weeks

Measure	Description	Time Frame
Recurrence rate of peptic ulcer		52 weeks

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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.

Exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katsuya Sugizaki	Drug Fostering and Evolution Coordination Department, Corporate Medical Affairs Headquarters, Eisai Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Nagoya			Japan

Condition Browse Module

MeSH Terms

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer
D012008	Recurrence

Ancestor Terms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided