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Nexium Capsules LDA Specific Clinical Experience Investigation

This study is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01729182
First received: November 14, 2012
Last updated: April 10, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition
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 LDA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Adverse events incidence [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Number of Adverse Drug Reactions


Secondary Outcome Measures:
  • Non-recurrence rate of peptic ulcer [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: January 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (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 Low dose Aspirin (LDA).

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.)

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729182

Contacts
Contact: AstraZeneca Clinical Study Information 8002369933 information.center@astrazeneca.com
Contact: AstraZeneca Information (Outside US) 0018002369933

Locations
Japan
Research Site Recruiting
Aichi, Japan
Research Site Recruiting
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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Hyogo, Japan
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Ibaraki, Japan
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Iwate, 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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Oita, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, 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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Tokyo, Japan
Research Site Recruiting
Tottori, Japan
Research Site Recruiting
Toyama, Japan
Research Site Recruiting
Wakayama, Japan
Research Site Recruiting
Yamagata, Japan
Research Site Recruiting
Yamaguchi, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD Astrazeneca K.K.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01729182     History of Changes
Other Study ID Numbers: D961PC00002
Study First Received: November 14, 2012
Last Updated: April 10, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Low dose Aspirin(LDA)
Gastric ulcer or duodenal ulcer
Nexium

Additional relevant MeSH terms:
Stomach Ulcer
Duodenal Ulcer
Ulcer
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
 Pathologic Processes
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013