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Nexium Capsules LDA Specific Clinical Experience Investigation

NCT ID: NCT01729182

Last Updated: 2019-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2363 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-03-09

Brief Summary

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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).

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Detailed Description

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Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with Low dose Aspirin (LDA).

Conditions

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Gastric Ulcer Duodenal Ulcer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Nexium

No interventions assigned to this group

Eligibility Criteria

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Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shigeru Yoshida, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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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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Countries

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Japan

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=709&filename=AZ%20Synopsis%20_D961PC00002.pdf

AZ\_Synopsis\_D961PC00002

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D961PC00002&attachmentIdentifier=3369ebc0-0d02-4d61-998f-b9321c317c64&fileName=NEX_SCEI_LDA_Protocol(E)_Ver3_redacted.pdf&versionIdentifier=

K. Sakamoto, M. Nii, T. Tokimoto and Y. Takumi Efficacy and Safety of Esomeprazole (Nexium) for the Prevention of Recurrent Gastric or Duodenal Ulcers in Patients on Continuous LDA; PMS of Long-term Use Jpn Pharmacol Ther, 47(6), 893 - 910, 2019

Other Identifiers

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D961PC00002

Identifier Type: -

Identifier Source: org_study_id

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