Nexium Capsules LDA 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 Low dose Aspirin (LDA).

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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

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Adverse events incidence

Time frame: Up to 2 years

Number of Adverse Drug Reactions

Secondary outcomes

Non-recurrence rate of peptic ulcer

Time frame: Up to 2 years

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 LDA

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2017
First posted: Nov 20, 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.

Published trials that share one or more normalized conditions with this study.

Completed