Omepral® Tablets Special Clinical Experience Investigatio... | NCT00859287

Studies
Omepral® Tablets Special Clinical Experience Investigation in Patients With Erosive Esophagitis

NCT00859287

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 15, 2009Estimated

Enrollment

10,703Actual

Phase

Not provided

Conditions

Reflux Esophagitis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2007

Primary Completion Date

Not provided

Completion Date

Jul 2008Actual

First Submitted Date

Mar 10, 2009

First Submission Date that Met QC Criteria

Mar 10, 2009

First Posted Date

Mar 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2009

Last Update Posted Date

Jul 15, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,703Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients symptom evaluated by investigator		at entry, 4 weeks and 8 weeks
Patients reported symptom		at entry, 4 weeks and 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patients reported outcome score		at entry, 4 weeks and 8 weeks
Adverse event		8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
AstraZeneca Japan Medical Director MD	AstraZeneca	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21356058	Derived	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.

ID	Term
D004941	Esophagitis
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases