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

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ClinicalTrials.gov Identifier: NCT00859287
Recruitment Status : Completed
First Posted : March 11, 2009
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease
Reflux Esophagitis

Study Type : Observational
Actual Enrollment : 10703 participants
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
Study Start Date : June 2007
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  1. Patients reported outcome score [ Time Frame: at entry, 4 weeks and 8 weeks ]
  2. Adverse event [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00859287


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

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
First Posted: March 11, 2009    Key Record Dates
Last Update Posted: July 15, 2009
Last Verified: July 2009

Keywords provided by AstraZeneca:
Reflux esophagitis
Omepral®
QOLRAD

Additional relevant MeSH terms:
Esophagitis
Esophagitis, Peptic
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases