Structured Treatment of Gastroesophageal Reflux in a Company Health Care Setting, -Effect on Quality of Life, Symptoms and Productivity

This study is not yet open for participant recruitment.

Verified by AstraZeneca, April 2009

First Received: April 17, 2009 No Changes Posted

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00884247

Purpose

The study aims to evaluate if a GERD treatment programme, in accordance with current regional recommendations, in a company health care setting, has an impact on health related quality of life (HRQoL), symptoms, and productivity in GERD patients.

Condition
GERD

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective, Non Interventional Study to Evaluate he Effects on Quality of Life, Symptoms and Productivity in Patients With Gastroesophageal Reflux Disease (GERD) After 6 Weeks Structured Treatment in a Company Health Care Setting

Resource links provided by NLM:

MedlinePlus related topics: GERD

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	April 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Company health care setting

Criteria

Inclusion Criteria:

Female and/or male aged > 18 years
Diagnosis of GERD confirmed
Prescription of GERD treatment or already receiving GERD treatment

Exclusion Criteria:

Any symptom suggesting a need for further investigation
Previous participation in the present study
Current participation in a clinical study or participation in a clinical study during the last 30 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884247

Contacts

Contact: AstraZeneca Sweden Medical Information

+ 46-8-553 26 000

lakemedelsinformation@astrazeneca.com

Locations

Sweden, Södertälje
Research Site
Hälsocenter, Södertälje, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Svante Svante, MD, PhD	AstraZeneca Sweden
Principal Investigator:	Dan Regberg, MD	AstraZeneca Sweden

More Information

No publications provided

Responsible Party:	AstraZeneca ( Svante Sjöstedt/MC MDOTA )
Study ID Numbers:	NIS-GSE-DUM-2009/1
Study First Received:	April 17, 2009
Last Updated:	April 17, 2009
ClinicalTrials.gov Identifier:	NCT00884247 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by AstraZeneca:

GERD
Quality of life
Structured treatment

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Quality of Life
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases

Gastrointestinal Diseases
Esophageal Diseases
Gastroesophageal Reflux

ClinicalTrials.gov processed this record on August 24, 2009