Back to resultsExamine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux focused on measuring GERD
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent, 18 years or older, diagnosis of GERD
Exclusion Criteria:
- Peptic ulcer disease, upper gastrointestinal surgery, malignancy
Sites / Locations
- Research Site
- Research Site
Outcomes
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00392002
Brief Title
Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response
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].
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
To characterize the burden of disease in GERD patients of prescription therapy'
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
Keywords
GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To examine the relationship of the severity and frequency of GERD symptoms to treatment, at national, and regional levels.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent, 18 years or older, diagnosis of GERD
Exclusion Criteria:
Peptic ulcer disease, upper gastrointestinal surgery, malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Canada Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23432146
Citation
Moayyedi P, Hunt R, Armstrong D, Lei Y, Bukoski M, White R. The impact of intensifying acid suppression on sleep disturbance related to gastro-oesophageal reflux disease in primary care. Aliment Pharmacol Ther. 2013 Apr;37(7):730-7. doi: 10.1111/apt.12254. Epub 2013 Feb 21.
Results Reference
derived
Learn more about this trial
Examine National Characteristics & Outcome Measures of GERD Patients Using the PPI Acid Suppression Symptom (PASS) Test for Response
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