Nexium Capsules RE Maintenance Specific Clinical Experience Investigation

October 30, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

647

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
      • Aomori, Japan
        • Research Site
      • Chiba, Japan
        • Research Site
      • Ehime, Japan
        • Research Site
      • Fukui, 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
      • Ishikawa, Japan
        • Research Site
      • Iwate, Japan
        • Research Site
      • Kagawa, Japan
        • Research Site
      • Kagoshima, 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
      • Miyazaki, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Nara, Japan
        • Research Site
      • Niigata, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Okayama, Japan
        • Research Site
      • Okinawa, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saga, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shiga, Japan
        • Research Site
      • Shimane, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tochigi, Japan
        • Research Site
      • Tokushima, Japan
        • Research Site
      • Tokyo, Japan
        • Research Site
      • Tottori, Japan
        • Research Site
      • Toyama, Japan
        • Research Site
      • Wakayama, Japan
        • Research Site
      • Yamagata, Japan
        • Research Site
      • Yamaguchi, 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 with repeatedly recurring/relapsing reflux oesophagitis who will be given Nexium for the first time as a maintenance therapy.

(Patients who had been given Nexium for the initial treatment for reflux oesophagitis can be enrolled to this investigation).

Description

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 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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Drug Reactions
Time Frame: 6 Month
Adverse event incidence
6 Month

Secondary Outcome Measures

Outcome Measure
Time Frame
Non-recurrence rate of reflux oesophagitis
Time Frame: 6 Month
6 Month

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

April 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 26, 2012

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 30, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961HC00013

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Repeatedly Recurring Esophagitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe