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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00859287
First received: March 10, 2009
Last updated: July 14, 2009
Last verified: July 2009
History of Changes
  Purpose

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.


Condition
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:

MedlinePlus related topics: GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Patients symptom evaluated by investigator [ Time Frame: at entry, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Patients reported symptom [ Time Frame: at entry, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients reported outcome score [ Time Frame: at entry, 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Adverse event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00859287

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Huvenne, Alain / Senior Medical Marketing Director, AstraZeneca Pharmaceuticals
ClinicalTrials.gov 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
Health Authority: Japan: Institutional Review Board

Keywords provided by AstraZeneca:
Reflux esophagitis
Omepral®
QOLRAD

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Gastroesophageal Reflux
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on May 22, 2013