The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT00901004
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-05-12
• Study First Posted: 2009-05-13
• Study Completion: 2009-09
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1550

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis	Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇰🇷 Suwon, Korea, Republic of