Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Completed

• Conditions: Gastric Ulcer; Lymphoma Idiopathic Thrombocytopenic Purpura; Duodenal Ulcer; Gastric Mucosa-associated Lymphoid Tissue (MALT); Early Gastric Cancer

• Registration Number: NCT01435525
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual post-marketing use.

Detailed Description

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-14
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 369

Inclusion Criteria

Not provided

Exclusion Criteria

• H.pylori negative at the time when the triple therapy is started

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Adverse Drug Reactions	Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Secondary Outcome Measures

Name	Time	Method
Rate of H.Pylori eradication	Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Trial Locations

Locations (1)

Research Site; 🇯🇵 Yamanashi, Japan