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Nexium Capsules Non-steroidal Anti-inflammatory Drug (NSAID) 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:
NCT01562600
First received: March 22, 2012
Last updated: April 9, 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 non-steroidal anti-inflammatory drug (NSAID).


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 NSAIDs

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Adverse Drug Reactions [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]
    Adverse event incidence


Secondary Outcome Measures:
  • Non-recurrence rate of peptic ulcer [ Time Frame: 1 Year ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: April 2012
Estimated Study Completion Date: September 2014

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
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.)

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562600

Contacts
Contact: Maki Inoue M.Inoue@astrazeneca.com

Locations
Japan
Research Unit Recruiting
Aichi, Japan
Research Unit Recruiting
Akita, Japan
Research Unit Recruiting
Aomori, Japan
Research Unit Recruiting
Chiba, Japan
Research Unit Recruiting
Ehime, Japan
Research Unit Recruiting
Fukui, Japan
Research Unit Recruiting
Fukuoka, Japan
Research Unit Recruiting
Fukushima, Japan
Research Unit Recruiting
Gifu, Japan
Research Unit Recruiting
Gunma, Japan
Research Unit Recruiting
Hiroshima, Japan
Research Unit Recruiting
Hokkaido, Japan
Research Unit Recruiting
Hyogo, Japan
Research Unit Recruiting
Ibaraki, Japan
Research Site Recruiting
Ishikawa, Japan
Research Unit Recruiting
Iwate, Japan
Research Unit Recruiting
Kagawa, Japan
Research Unit Recruiting
Kagoshima, Japan
Research Unit Recruiting
Kanagawa, Japan
Research Unit Recruiting
Kochi, Japan
Research Unit Recruiting
Kumamoto, Japan
Research Unit Recruiting
Kyoto, Japan
Research Unit Recruiting
Miyagi, Japan
Research Unit Recruiting
Miyazaki, Japan
Research Unit Recruiting
Nagano, Japan
Research Unit Recruiting
Nagasaki, Japan
Research Unit Recruiting
Nara, Japan
Research Unit Recruiting
Niigata, Japan
Research Unit Recruiting
Oita, Japan
Research Unit Recruiting
Okayama, Japan
Research Unit Recruiting
Osaka, Japan
Research Unit Recruiting
Saga, Japan
Research Unit Recruiting
Saitama, Japan
Research Unit Recruiting
Shiga, Japan
Research Unit Completed
Shimane, Japan
Research Unit Recruiting
Shizuoka, Japan
Research Unit Recruiting
Tochigi, Japan
Research Unit Completed
Tokushima, Japan
Research Unit Recruiting
Tokyo, Japan
Research Site Active, not recruiting
Tottori, Japan
Research Unit Recruiting
Toyama, Japan
Research Unit Recruiting
Wakayama, Japan
Research Site Not yet recruiting
Yamagata, Japan
Research Unit Recruiting
Yamaguchi, Japan
Research Unit Recruiting
Yamanashi, 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: NCT01562600     History of Changes
Other Study ID Numbers: D961HC00012
Study First Received: March 22, 2012
Last Updated: April 9, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
NSAIDs
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
 Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 13, 2013