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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: March 10, 2009
Last updated: July 14, 2009
Last verified: July 2009
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.

Reflux Esophagitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Omepral® Tablets Mega-study to Investigate the Efficacy on Various Type of Acid Reflux Related Symptoms and QOL, and Epidemiology in Patients With Erosive Esophagitis in Daily Medical Practice

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patients symptom evaluated by investigator [ Time Frame: at entry, 4 weeks and 8 weeks ]
  • Patients reported symptom [ Time Frame: at entry, 4 weeks and 8 weeks ]

Secondary Outcome Measures:
  • Patients reported outcome score [ Time Frame: at entry, 4 weeks and 8 weeks ]
  • Adverse event [ Time Frame: 8 weeks ]

Enrollment: 10703
Study Start Date: June 2007
Study Completion Date: July 2008

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   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

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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00859287

Sponsors and Collaborators
Study Director: AstraZeneca Japan Medical Director MD AstraZeneca
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Huvenne, Alain / Senior Medical Marketing Director, AstraZeneca Pharmaceuticals Identifier: NCT00859287     History of Changes
Other Study ID Numbers: NIS-GJP-DUM-2007/1
Study First Received: March 10, 2009
Last Updated: July 14, 2009

Keywords provided by AstraZeneca:
Reflux esophagitis

Additional relevant MeSH terms:
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases processed this record on May 22, 2017