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Completed

NCT Number: NCT01562600

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

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).

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Key information

Conditions

Gastric Ulcer Digestive System Diseases Duodenal Diseases Duodenal Ulcer Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Stomach Diseases Stomach Ulcer

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Number of Adverse Drug Reactions

    Time frame: 1 Year

    Adverse event incidence

Secondary outcomes

  1. Non-recurrence rate of peptic ulcer

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Nexium Capsules Specific Clinical Experience Investigation for Long-term Use Concerning Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer With NSAIDs

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2012
Registry last updated
Aug 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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