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Nexium Capsules LDA Specific Clinical Experience Investigation

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ClinicalTrials.gov Identifier: NCT01729182
Recruitment Status : Completed
First Posted : November 20, 2012
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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 Low dose Aspirin (LDA).

Condition or disease
Gastric Ulcer Duodenal Ulcer

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).

Study Type : Observational
Actual Enrollment : 2363 participants
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
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : March 9, 2017
Actual Study Completion Date : March 9, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Nexium



Primary Outcome Measures :
  1. Adverse events incidence [ Time Frame: Up to 2 years ]
    Number of Adverse Drug Reactions


Secondary Outcome Measures :
  1. Non-recurrence rate of peptic ulcer [ Time Frame: Up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01729182


Locations
Japan
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
Research Site
Gunma, Japan
Research Site
Hiroshima, Japan
Research Site
Hokkaido, Japan
Research Site
Hyogo, Japan
Research Site
Ibaraki, Japan
Research Site
Ishikawa, Japan
Research Site
Iwate, Japan
Research Site
Kagawa, Japan
Research Site
Kagoshima, Japan
Research Site
Kanagawa, Japan
Research Site
Kochi, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Mie, Japan
Research Site
Miyagi, Japan
Research Site
Miyazaki, Japan
Research Site
Nagano, Japan
Research Site
Nagasaki, Japan
Research Site
Nara, Japan
Research Site
Niigata, Japan
Research Site
Oita, Japan
Research Site
Okayama, Japan
Research Site
Okinawa, Japan
Research Site
Osaka, Japan
Research Site
Saga, Japan
Research Site
Saitama, Japan
Research Site
Shiga, Japan
Research Site
Shimane, Japan
Research Site
Shizuoka, Japan
Research Site
Tochigi, Japan
Research Site
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
AstraZeneca
Investigators
Study Director: Shigeru Yoshida, MD AstraZeneca K.K.

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01729182     History of Changes
Other Study ID Numbers: D961PC00002
First Posted: November 20, 2012    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018

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

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Duodenal Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action