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

Gastroesophageal Reflux Clinical Trial

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].

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392002
• Other study ID #: D9612L00096
• Secondary ID: EncomPASS
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2006
• Last updated: January 24, 2008
• Start date: October 2005
• Est. completion date: May 2007

Study information

• Verified date: January 2008
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Peptic ulcer disease, upper gastrointestinal surgery, malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Esomeprazole

Locations

Country	Name	City	State
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.