ClinicalTrials.gg
Sign In
CompletedNCT00859287OMAREEUpdated Jul 15, 2009

Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis

An observational study in Reflux Esophagitis, sponsored by AstraZeneca. Completed. Per ClinicalTrials.gov, last updated 2009-07-15.

Sponsored by AstraZeneca · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,703
Sex
All
01

Study summary

This open label, non-interventional study is to compare the efficacy of Omepral® tablet and any other treatments excepting proton pump inhibitors (PPIs) for the treatment of various type of acid reflux related symptoms in patients with reflux esophagitis.

02

Conditions studied

  • Reflux Esophagitis

Browse trials for

Keywords

  • Reflux esophagitis
  • Omepral®
  • QOLRAD
03

In context

Esophagitis, Peptic

316 studies on the registry are indexed under Esophagitis, Peptic; 33 are open to participants now.

This study's enrollment of 10,703 is above the median of 120 across 84 observational studies indexed under Esophagitis, Peptic.

Browse Esophagitis, Peptic studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Browse AstraZeneca studies →

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 endoscopically diagnosed as erosive esophagitis accompanied with either two days or more heartburn or acid taste in the mouth of any severity

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients newly diagnosed as erosive esophagitis or history of erosive esophagitis confirmed by endoscopy.
  • Patients who answered questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
  • During the past 1 week , patients who have either two days or more with heartburn or acid taste in the mouth of any severity

Exclusion criteria

Exclusion Criteria:

  • Patients receiving treatment with proton pump inhibitors, which make stomach acid decreased during the last 4 weeks prior to enrolment.
  • Patients who cannot answer questionnaires of quality of life (QOLRAD-J), symptom severity and frequency and treatment satisfaction.
  • Patients included previously in this study.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,703 participants (actual)
06

What researchers measure

Primary outcomes

  1. Patients symptom evaluated by investigator

    Time frame: at entry, 4 weeks and 8 weeks

  2. Patients reported symptom

    Time frame: at entry, 4 weeks and 8 weeks

Secondary outcomes

  1. Patients reported outcome score

    Time frame: at entry, 4 weeks and 8 weeks

  2. Adverse event

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Yoshida S, Nii M, Date M. Effects of omeprazole on symptoms and quality of life in Japanese patients with reflux esophagitis: final results of OMAREE, a large-scale clinical experience investigation. BMC Gastroenterol. 2011 Feb 28;11:15. doi: 10.1186/1471-230X-11-15. PubMed 21356058 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00859287
Lead sponsor
AstraZeneca
First posted
Mar 11, 2009
Start date
Jun 2007
Completion
Jul 2008
Last update
Jul 15, 2009

Study contacts

AstraZeneca Japan Medical Director MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Esophagitis, Peptic →

Other studies from this sponsor

AstraZeneca →

Start the discussion