- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01562600
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
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aichi, Japan
- Research Site
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Akita, Japan
- Research Site
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Aomori, Japan
- Research Site
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Chiba, Japan
- Research Site
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Ehime, Japan
- Research Site
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Fukui, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Fukushima, Japan
- Research Site
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Gifu, Japan
- Research Site
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Gunma, Japan
- Research Site
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Hiroshima, Japan
- Research Site
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Hokkaido, Japan
- Research Site
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Hyogo, Japan
- Research Site
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Ibaraki, Japan
- Research Site
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Ishikawa, Japan
- Research Site
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Iwate, Japan
- Research Site
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Kagawa, Japan
- Research Site
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Kagoshima, Japan
- Research Site
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Kanagawa, Japan
- Research Site
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Kochi, Japan
- Research Site
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Kumamoto, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Mie, Japan
- Research Site
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Miyagi, Japan
- Research Site
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Miyazaki, Japan
- Research Site
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Nagano, Japan
- Research Site
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Nagasaki, Japan
- Research Site
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Nara, Japan
- Research Site
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Niigata, Japan
- Research Site
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Oita, Japan
- Research Site
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Okayama, Japan
- Research Site
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Osaka, Japan
- Research Site
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Saga, Japan
- Research Site
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Saitama, Japan
- Research Site
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Shiga, Japan
- Research Site
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Shimane, Japan
- Research Site
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Shizuoka, Japan
- Research Site
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Tochigi, Japan
- Research Site
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Tokushima, Japan
- Research Site
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Tokyo, Japan
- Research Site
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Tottori, Japan
- Research Site
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Toyama, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Yamagata, Japan
- Research Site
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Yamaguchi, Japan
- Research Site
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Yamanashi, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.)
Description
Inclusion 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.
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Nexium
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Drug Reactions
Time Frame: 1 Year
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Adverse event incidence
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1 Year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Non-recurrence rate of peptic ulcer
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D961HC00012
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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