NCT01729182

Brief Summary

The purpose of this investigation is to collect following data in patients given Nexium capsule (Nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,363

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

47 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

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2017

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

4.2 years

First QC Date

November 14, 2012

Last Update Submit

August 5, 2019

Conditions

Gastric UlcerDuodenal Ulcer

Keywords

Low dose Aspirin(LDA)Gastric ulcer or duodenal ulcerNexium

Outcome Measures

Primary Outcomes (1)

  • Adverse events incidence

    Number of Adverse Drug Reactions

    Up to 2 years

Secondary Outcomes (1)

  • Non-recurrence rate of peptic ulcer

    Up to 2 years

Study Arms (1)

Nexium

Eligibility Criteria

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

The patients who are continuously given Low dose Aspirin (LDA) to suppress thrombus/embolism and who will be given Nexium for the first time to suppress recurrence of gastric ulcer and duodenal ulcer. (Patients who have previous experience of Nexium given in the treatment for gastric ulcer or duodenal ulcer can be registered to this S-CEI.)

You may not qualify if:

  • Patients having gastric ulcer/duodenal ulcer when Nexium is started (Active phase (A1, A2) or healing phase (H1, H2) of Sakita-Miwa classification on endoscopy).
  • Patients who had been given Nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (47)

Research Site

Aichi, Japan

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Akita, Japan

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Aomori, Japan

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Chiba, Japan

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Ehime, Japan

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Fukui, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Gifu, Japan

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Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Ibaraki, Japan

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Ishikawa, Japan

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Kagawa, Japan

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Kagoshima, Japan

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Kanagawa, Japan

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Kochi, Japan

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Kumamoto, Japan

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Kyoto, Japan

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Mie, Japan

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Miyagi, Japan

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Miyazaki, Japan

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Nagano, Japan

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Nagasaki, Japan

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Nara, Japan

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Niigata, Japan

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Numakunai, Japan

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Okayama, Japan

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Okinawa, Japan

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Osaka, Japan

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Ōita, Japan

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Saga, Japan

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Saitama, Japan

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Shiga, Japan

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Shimane, Japan

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Shizuoka, Japan

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Tochigi, Japan

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Tokushima, Japan

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Tokyo, Japan

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Tottori, Japan

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Toyama, Japan

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Wakayama, Japan

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Yamagata, Japan

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Yamaguchi, Japan

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Yamanashi, Japan

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Related Links

MeSH Terms

Conditions

Stomach UlcerDuodenal Ulcer

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Study Officials

  • Shigeru Yoshida, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

January 1, 2013

Primary Completion

March 9, 2017

Study Completion

March 9, 2017

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

JP(47)