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

March 10, 2009
July 14, 2009
June 2007
Not Provided
  • 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 ]
Same as current
Complete list of historical versions of study NCT00859287 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Reflux Esophagitis
Not Provided
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10703
July 2008
Not Provided

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00859287
NIS-GJP-DUM-2007/1
No
Huvenne, Alain / Senior Medical Marketing Director, AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: AstraZeneca Japan Medical Director MD AstraZeneca
AstraZeneca
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP