Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation
Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs
1 other identifier
observational
1,634
1 country
46
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 non-steroidal anti-inflammatory drug (NSAID).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2012
Typical duration for all trials
46 active sites
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
March 22, 2012
CompletedFirst Posted
Study publicly available on registry
March 26, 2012
CompletedStudy Start
First participant enrolled
April 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2015
CompletedAugust 7, 2019
August 1, 2019
3.4 years
March 22, 2012
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Adverse Drug Reactions
Adverse event incidence
1 Year
Secondary Outcomes (1)
Non-recurrence rate of peptic ulcer
1 Year
Study Arms (1)
Nexium
Eligibility Criteria
Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or 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 qualify if:
- Patients who are given NSAIDs for long terms to control pain due to disease such as rheumatoid arthritis and osteoarthritis, and given Nexium to suppress recurrence of gastric ulcer or duodenal ulcer.
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
- AstraZenecalead
Study Sites (46)
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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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
Related Links
- AZ\_Synopsis\_D961HC00012\_STUDY\_REPORT\_SUMMARY\_revised
- K. Sakamoto, M. Nii, T. Tokimoto and Y. Takumi Esomeprazole (Nexium) Specific Clinical Experience Investigation for Long-term Use in the Prevention of the Recurrence of Gastric or Duodenal Ulcer with NSAIDs Jpn Pharmacol Ther, 47(7), 1043 - 1057, 2019
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shigeru Yoshida, MD
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2012
First Posted
March 26, 2012
Study Start
April 19, 2012
Primary Completion
August 27, 2015
Study Completion
August 27, 2015
Last Updated
August 7, 2019
Record last verified: 2019-08