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

Completed

• Conditions: Gastric Ulcer; Duodenal Ulcer

• Registration Number: NCT01562600
• 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 non-steroidal anti-inflammatory drug (NSAID).

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Study Start: 2012-04-19
• Primary Completion: 2015-08-27
• Study Completion: 2015-08-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1634

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Adverse Drug Reactions	1 Year	Adverse event incidence

Secondary Outcome Measures

Name	Time	Method
Non-recurrence rate of peptic ulcer	1 Year

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan