Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

April 14, 2014 updated by: AstraZeneca

Nexium Capsules Specific Clinical Experience Investigation Concerning Helicobacter Pylori Eradication

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Study Type

Observational

Enrollment (Actual)

369

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Aichi, Japan
        • Research Site
      • Akita, Japan
        • Research Site
      • Chiba, Japan
        • Research Site
      • Ehime, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Fukushima, Japan
        • Research Site
      • Gifu, Japan
        • Research Site
      • Gunma, Japan
        • Research Site
      • Hiroshima, Japan
        • Research Site
      • Hokkaido, Japan
        • Research Site
      • Hyogo, Japan
        • Research Site
      • Ibaraki, Japan
        • Research Site
      • Iwate, Japan
        • Research Site
      • Kagawa, Japan
        • Research Site
      • Kanagawa, Japan
        • Research Site
      • Kochi, Japan
        • Research Site
      • Kumamoto, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Mie, Japan
        • Research Site
      • Miyagi, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Okinawa, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shiga, Japan
        • Research Site
      • Shimane, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Yamagata, Japan
        • Research Site
      • Yamanashi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients to whom triple therapy for H.pylori eradication to stomach is started after endoscopic treatment for gastric ulcer, duodenal ulcer, gastric MALT lymphoma, idiopathic thrombocytopenic purpura, or early gastric cancer as the approved indication of Nexium. Patients with H.pylori negative at the time when the triple therapy is started are excluded.

Description

Inclusion criteria:

  • Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric ulcer
  • Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for duodenal ulcer
  • Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric MALT lymphoma
  • Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for idiopathic thrombocytopenic purpura
  • Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for early gastric cancer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Adverse Drug Reactions
Time Frame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months
Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of H.Pylori eradication
Time Frame: Period from the start of triple therapy to assessment of eradication, an expected average of 3 months
Period from the start of triple therapy to assessment of eradication, an expected average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

September 14, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961HC00011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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