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Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) Specific Clinical Experience Investigation

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: March 22, 2012
Last updated: June 9, 2016
Last verified: June 2016
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).

Gastric Ulcer
Duodenal Ulcer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Adverse Drug Reactions [ Time Frame: 1 Year ]
    Adverse event incidence

Secondary Outcome Measures:
  • Non-recurrence rate of peptic ulcer [ Time Frame: 1 Year ]

Enrollment: 1634
Study Start Date: April 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Detailed Description:
Nexium capsules Specific Clinical Experience Investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with NSAIDs

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.)


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.
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Please refer to this study by its identifier: NCT01562600

Research Site
Aichi, Japan
Research Site
Akita, Japan
Research Site
Aomori, Japan
Research Site
Chiba, Japan
Research Site
Ehime, Japan
Research Site
Fukui, Japan
Research Site
Fukuoka, Japan
Research Site
Fukushima, Japan
Research Site
Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyogo, Japan
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Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
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Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
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Kumamoto, Japan
Research Site
Kyoto, Japan
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Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
Research Site
Oita, Japan
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Okayama, Japan
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Osaka, Japan
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Saga, Japan
Research Site
Saitama, Japan
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Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
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Tokushima, Japan
Research Site
Tokyo, Japan
Research Site
Tottori, Japan
Research Site
Toyama, Japan
Research Site
Wakayama, Japan
Research Site
Yamagata, Japan
Research Site
Yamaguchi, Japan
Research Site
Yamanashi, Japan
Sponsors and Collaborators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT01562600     History of Changes
Other Study ID Numbers: D961HC00012
Study First Received: March 22, 2012
Last Updated: June 9, 2016

Keywords provided by AstraZeneca:
Gastric ulcer or duodenal ulcer

Additional relevant MeSH terms:
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 22, 2017