Prevalence of Gastroesophageal Reflux Disease in Primary... | NCT01020890 | Trialant

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Prevalence of Gastroesophageal Reflux Disease in Primary... | NCT01020890 | Trialant

Studies
Prevalence of Gastroesophageal Reflux Disease in Primary Care Patients With Upper Gastrointestinal Symptoms

NCT01020890

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 12, 2010Estimated

Enrollment

2,210Actual

Phase

Not provided

Conditions

Gastroesophageal Reflux Disease

Interventions

Not provided

Countries

Bulgaria

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

NCT01020890

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

NIS-GBG-NEX-2009/1

Secondary IDs

Not provided

Brief Title

Prevalence of Gastroesophageal Reflux Disease in Primary Care Patients With Upper Gastrointestinal Symptoms

Official Title

A Cross-sectional Study on the Prevalence of GERD in Primary Care Patients With Upper GI Symptoms Using the GERD-Q. The Bulgarian GERD-Q Study

Acronym

Not provided

Organization

AstraZenecaINDUSTRY

Status Module

Record Verification Date

Jul 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

No

Start Date

Nov 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Nov 25, 2009

First Submission Date that Met QC Criteria

Nov 25, 2009

First Posted Date

Nov 26, 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 9, 2010

Last Update Posted Date

Jul 12, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

AstraZenecaINDUSTRY

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

No

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 provide data on the gastroesophageal reflux disease (GERD) prevalence as percentage of patients with upper gastrointestinal (GI) symptoms that are identified with GERD using the Gerd-Q Questionnaire.

Detailed Description

Not provided

Conditions Module

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD diagnosis
GERD-Q
GERD patients' characteristics
GERD

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

2,210Actual

Arms/Interventions Module

No data available

No data is available for this block.

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with upper gastrointestinal symptoms

Exclusion Criteria:

History of oesophageal, gastric or duodenal surgery
Current treatment with antiinflammatory drugs, including OTC
Current treatment with proton pump inhibitors ang H2-blockers

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Blagoevgrad			Bulgaria
Research Site

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Not provided

Intervention Model Description

Not provided

Primary Purpose

Not provided

Observational Model

Not provided

Time Perspective

Cross-Sectional

Masking Info

No data available

No data is available for this block.

Burgas

Bulgaria

Research Site

Dobrich

Bulgaria

Research Site

Pleven

Bulgaria

Research Site

Plovdiv

Bulgaria

Research Site

Rousse

Bulgaria

Research Site

Sofia

Bulgaria

Research Site

Stara Zagora

Bulgaria

Research Site

Varna

Bulgaria

Research Site

Veliko Tarnovo

Bulgaria

Research Site

Vratsa

Bulgaria

Research Site

Yambol

Bulgaria

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided