Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response

This study has been completed.

First Received: October 24, 2006 Last Updated: January 24, 2008 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00392002

Purpose

To characterize the burden of disease in GERD patients of prescription therapy'

Condition	Intervention	Phase
Gastroesophageal Reflux	Drug: Esomeprazole	Phase IV

MedlinePlus related topics: GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Cluster-Randomized Study to Examine National Characteristics and Outcome Measures of GERD Patients Utilizing the PPI Acid Suppression Symptom (PASS) Test for Response [EncomPASS].

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare the improvement in burden of overall GERD symptoms after 4 weeks of treatment with Esomeprazole verses maintenance of current therapy in subjects with persistent GERD symptoms.

Secondary Outcome Measures:

To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.

Estimated Enrollment:	2000
Study Start Date:	October 2005
Study Completion Date:	May 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed informed consent, 18 years or older, diagnosis of GERD

Exclusion Criteria:

Peptic ulcer disease, upper gastrointestinal surgery, malignancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392002

Locations

Canada, Ontario
Research Site
Mississauga, Ontario, Canada
Research Site
Toronto, Ontario, Canada

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Canada Medical Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00096, EncomPASS
Study First Received:	October 24, 2006
Last Updated:	January 24, 2008
ClinicalTrials.gov Identifier:	NCT00392002 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

GERD

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Digestive System Diseases
Esophageal Disorder

Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Gastroesophageal Reflux
Pharmacologic Actions

Esophageal Motility Disorders
Deglutition Disorders
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases

ClinicalTrials.gov processed this record on May 07, 2009