The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire
MIGHT
Non-interventional, Cross-sectional, Multi-center Study to Establish The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire (GerdQ)
1 other identifier
observational
1,550
1 country
7
Brief Summary
The purpose of this study is to define the endoscopic findings of minimal change that is significant to clinical significant reflux esophagitis. Through this, the investigators want to estimate the applicability of minimal change findings of reflux esophagitis to the clinic.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
Shorter than P25 for all trials
7 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
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 28, 2009
CompletedFirst Posted
Study publicly available on registry
May 13, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedDecember 7, 2010
December 1, 2010
April 28, 2009
December 6, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis
Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis
Secondary Outcomes (1)
To establish the probability model of diagnosing gastroesophageal reflux disease based on minimal change endoscopic findings through definition of significant minimal change endoscopic findings of gastroesophageal reflux disease diagnosis.
at baseline -->this is a cross-sectional study
Study Arms (1)
1
Reflux esophageal minimal change in the endoscopic finding
Eligibility Criteria
Patients who had shown the reflux esophageal minimal change in the endoscopic finding
You may qualify if:
- Age ≥ 20 years old patients who consent to revealing their medical information and be able to respond to questionnaires regarding the symptom.
- Patients who had shown the reflux esophageal minimal change in the endoscopic finding: the reflux esophagitis
You may not qualify if:
- Patients who had shown the mucosal break or barrett esophagus at gastric mucosal barrier or lower oesophagus in endoscopic findings
- Patient with a diagnosis of gastroesophageal reflux disease and who have received medication treatment
- Patient who had received H2-receptor antagonists, prostaglandin, PPI, NSAIDs or aspirin, high dose steroid and anticoagulants for at least 5 consecutive days in the 4-week period immediately preceding the diagnostic endoscopy
- Patients with a history of operation due to gastrointestinal disease, malignancy, alcoholism, pregnancy (in female), breast feeding (in female) or systemic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (7)
Research Site
Busan, South Korea
Research Site
Daegu, South Korea
Research Site
Daejun, South Korea
Research Site
Kwangju, South Korea
Research Site
Seoul, South Korea
Research Site
Sungman, South Korea
Research Site
Suwon, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Joonwoo Bahn
Astrazenca Korea, Medical Department
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 28, 2009
First Posted
May 13, 2009
Study Start
April 1, 2009
Study Completion
September 1, 2009
Last Updated
December 7, 2010
Record last verified: 2010-12