Nexium Capsules RE Maintenance Specific Clinical Experience Investigation

Completed

• Conditions: Relapsing Reflux Esophagitis; Repeatedly Recurring Esophagitis

• Registration Number: NCT01562639
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to collect following data in patients given Nexium capsule (Nexium) in usual post-marketing use as the maintenance therapy for repeatedly recurring/relapsing reflux oesophagitis.

Detailed Description

Nexium capsules Specific Clinical Experience Investigation for Maintenance Therapy for Repeatedly Recurring/Relapsing Reflux Oesophagitis

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
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-30
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 647

Inclusion Criteria

• Patients with repeatedly recurring/relapsing reflux oesophagitis who will be given Nexium for the first time as a maintenance therapy.

Exclusion Criteria

• Patients having reflux oesophagitis when Nexium is started (Grade A, Grade B, Grade C or Grade D of Los Angeles Classification (Hoshihara's modification) on endoscopy)
• Patients having previous history of maintenance therapy for repeatedly recurring/ relapsing reflux oesophagitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Adverse Drug Reactions	6 Month	Adverse event incidence

Secondary Outcome Measures

Name	Time	Method
Non-recurrence rate of reflux oesophagitis	6 Month

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan