Epidemiological Study to Assess the Symptoms and Patterns... | NCT00524355

Studies
Epidemiological Study to Assess the Symptoms and Patterns of Diagnosis and Treatment of GERD

NCT00524355

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Jul 17, 2009Estimated

Enrollment

2,717Actual

Phase

Not provided

Conditions

GERD

Interventions

Not provided

Countries

Vietnam

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

ID	Type	Description	Link
NIS-G84-GER-2007/2

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

Mar 2007

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Aug 30, 2007

First Submission Date that Met QC Criteria

Aug 30, 2007

First Posted Date

Sep 3, 2007Estimated

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 16, 2009

Last Update Posted Date

Jul 17, 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

To describe the frequency, type and severity of the symptoms in patients visiting the GI or internal physicians, with symptoms consistent with gastroesophageal reflux disease (GERD)

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

2,717Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients from both sexes, aged 18 years or older
Patients complaining of symptoms consistent with reflux disease

Exclusion Criteria:

Patients with GI cancer and those where the only reason for the visit is renewing the prescription are excluded

Accepts Healthy Volunteers

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 clinics, private clinics and out-patient department at hospitals in cities and provinces of Viet Nam

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ta Long, MD, PhD	108 Hospital, Hanoi	Study Chair
Do Van Dung, MD, PhD	Ho Chi Minh City Univ of Medicine and Pharmacist	Study Chair
Dao Van Long, MD, PhD	Ha Noi University of Medicine Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Hanoi			Vietnam
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux
D006356	Heartburn

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