NCT00859287

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,703

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2007

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 11, 2009

Completed
Last Updated

July 15, 2009

Status Verified

July 1, 2009

First QC Date

March 10, 2009

Last Update Submit

July 14, 2009

Conditions

Reflux Esophagitis

Keywords

Reflux esophagitisOmepral®QOLRAD

Outcome Measures

Primary Outcomes (2)

  • Patients symptom evaluated by investigator

    at entry, 4 weeks and 8 weeks

  • Patients reported symptom

    at entry, 4 weeks and 8 weeks

Secondary Outcomes (2)

  • Patients reported outcome score

    at entry, 4 weeks and 8 weeks

  • Adverse event

    8 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 21356058DERIVED

MeSH Terms

Conditions

Esophagitis, Peptic

Condition Hierarchy (Ancestors)

EsophagitisEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritisPeptic UlcerDuodenal DiseasesIntestinal DiseasesStomach Diseases

Study Officials

  • AstraZeneca Japan Medical Director MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 10, 2009

First Posted

March 11, 2009

Study Start

June 1, 2007

Study Completion

July 1, 2008

Last Updated

July 15, 2009

Record last verified: 2009-07