NCT01562639

Completed

Nexium Capsules RE Maintenance Specific Clinical Experience ...

AstraZeneca Source

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Other study identifiers

Sponsor study identifier

D961HC00013

Study Type

observational

Actual enrollment (reported)

647

Locations

1 country

Sites

46

Timeline

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2014

Actual (reported)

Study Completion

July 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 647 participants
Study completion date: July 2014
Actual (reported)
Listed locations: 1 countries · 46 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
March 22, 2012
Actual (reported)
First Posted
March 26, 2012
Actual (reported)
Study Start
April 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2014
Actual (reported)
Study Completion
July 2014
Actual (reported)

Last Updated: October 31, 2014
Status Verified: October 2014
Last Update Submitted: October 30, 2014

Conditions

Relapsing Reflux Esophagitis Repeatedly Recurring Esophagitis

Keywords

maintenance therapy,repeatedly recurring,relapsing reflux oesophagitis,Nexium

Outcome Measures

Primary Outcomes (1)

Number of Adverse Drug Reactions
Adverse event incidence
6 Month

Secondary Outcomes (1)

Non-recurrence rate of reflux oesophagitis
6 Month

Study Arms (1)

Nexium

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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).

You may qualify if:

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

Sponsors & Collaborators

AstraZeneca
Industrylead

Study Sites (46)

Research Site

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

Study Officials

Shigeru Yoshida, MD
AstraZeneca
STUDY DIRECTOR

Enrollment

647 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 26, 2012

Study Start

April 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Fukushima, Japan

Research Site

Gifu, Japan

Research Site

Gunma, Japan

Research Site

Hiroshima, Japan

Research Site

Hokkaido, Japan

Research Site

Hyōgo, Japan

Research Site

Ibaraki, Japan

Research Site

Ishikawa, 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

Numakunai, Japan

Research Site

Okayama, Japan

Research Site

Okinawa, Japan

Research Site

Osaka, Japan

Research Site

Ōita, 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

Primary Completion

July 2014

Actual (reported)

Study Completion

July 2014

Actual (reported)

Last Updated

October 31, 2014

Record last verified: 2014-10

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01562639
Data provider: ClinicalTrials.gov
Source updated: 2014-10-31
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:15 UTC

Locations

JP(46)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Nexium

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (46)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations