Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease
A Prospective, Observational Study to Describe Symptom Control and Impact on Daily Life in Patients With Gastroesophageal Reflux Disease (GERD)
1 other identifier
observational
1,000
1 country
2
Brief Summary
The purpose of this study is to evaluate the impact of gastroesophageal reflux disease (GERD) treatment in primary care setting on symptom control and daily life in symptomatic GERD patients, using both GERD questionnaire and clinical symptoms assessment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2011
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedMay 10, 2012
May 1, 2012
7 months
September 9, 2011
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percent change in intensity and frequency for each of typical GERD symptoms from baseline to week 4-6
Day 0 to week 4-6
Changes in GERD questionnaire(GERD-Q) scores from baseline to week 4-6
Day 0 to week 4-6
Secondary Outcomes (1)
To evaluate the correlation between GERD-Q scores and symptom scores
two times
Study Arms (1)
1
Eligibility Criteria
primary care setting
You may qualify if:
- Patients known or newly diagnosed with GERD
- Patients with typical GERD symptoms as heartburn and regurgitation for ≥2 days in the previous week
- Patients, currently not treated with a proton pump inhibitor
You may not qualify if:
- Patients with medical history of surgery of the esophagus, stomach or duodenum
- Pregnant or nursing females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (2)
Unknown Facility
Sofia, Bulgaria
Unknown Facility
Varna, Bulgaria
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 13, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
May 10, 2012
Record last verified: 2012-05