Nexium Capsules LDA Specific Clinical Experience Investigation

Completed

• Conditions: Gastric Ulcer; Duodenal Ulcer

• Registration Number: NCT01729182
• Lead Sponsor: 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).

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 Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-14
• Study First Posted: 2012-11-20
• Study Start: 2013-01-01
• Primary Completion: 2017-03-09
• Study Completion: 2017-03-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2363

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events incidence	Up to 2 years	Number of Adverse Drug Reactions

Secondary Outcome Measures

Name	Time	Method
Non-recurrence rate of peptic ulcer	Up to 2 years

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan