Prevalence of EED and Quality of Life Evaluated by Gastro... | NCT00768196

Studies
Prevalence of EED and Quality of Life Evaluated by Gastroesophageal Reflux Disease (GERD)-Q in Korean GERD Patients

NCT00768196

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 7, 2010Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease

Interventions

Not provided

Countries

South Korea

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

Dec 2010

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

Sep 2008

Primary Completion Date

Not provided

Completion Date

Feb 2009Actual

First Submitted Date

Oct 1, 2008

First Submission Date that Met QC Criteria

Oct 6, 2008

First Posted Date

Oct 7, 2008Estimated

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

Dec 6, 2010

Last Update Posted Date

Dec 7, 2010Estimated

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

The purpose of this study is to asses the EED symptom prevalence in Koran GERD patients with typical reflux symptom and to evaluate quality of life with the scales including Gerd Q.

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

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary variable is the total rate of GERD patients who had EED symptom and effect on their quality of life.

Secondary Outcomes

Measure	Description	Time Frame
The secondary variable is the comparison of the EED symptom frequency in ERD and NERD patients.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

GERD patients who have experienced heartburn or acid regurgitation during past 7 days
GERD patients who have already undergone endoscopy before enrolment

Exclusion Criteria:

Involvement in the planning and conduct of the programme
The person who took the medicine such as PPI or H2RA during the last 7 days
Severe systemic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

general hospital sample

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joon-Woo Bahn	AstraZeneca Korea	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Cheonan	Chungcheongnam-do		South Korea
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided