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CompletedNCT01562639Updated Oct 31, 2014

Nexium Capsules RE Maintenance Specific Clinical Experience Investigation

An observational study in Repeatedly Recurring Esophagitis and Relapsing Reflux Esophagitis, sponsored by AstraZeneca. Completed at 46 sites in Japan. Per ClinicalTrials.gov, last updated 2014-10-31.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
647
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Repeatedly Recurring Esophagitis
  • Relapsing Reflux Esophagitis

Keywords

  • maintenance therapy,
  • repeatedly recurring,
  • relapsing reflux oesophagitis,
  • Nexium
03

In context

Esophagitis

322 studies on the registry are indexed under Esophagitis; 37 are open to participants now.

This study's enrollment of 647 is above the median of 100 across 91 observational studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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).

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
647 participants (actual)

Groups and cohorts

  • Nexium
06

What researchers measure

Primary outcomes

  1. Number of Adverse Drug Reactions

    Adverse event incidence

    Time frame: 6 Month

Secondary outcomes

  1. Non-recurrence rate of reflux oesophagitis

    Time frame: 6 Month

07

Study locations

46 sites
  • 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
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01562639
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Mar 26, 2012
Start date
Apr 2012
Primary completion
Jul 2014
Completion
Jul 2014
Last update
Oct 31, 2014

Study contacts

Shigeru Yoshida, MD
study director · AstraZeneca K.K.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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