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

Gastroesophageal Reflux Disease Clinical Trial

— MIGHT  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00901004
• Other study ID #: NIS-GKR-DUM-2009/1
• Status: Completed
• Phase: N/A
• First received: April 28, 2009
• Last updated: December 6, 2010
• Start date: April 2009
• Est. completion date: September 2009

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1550
• Est. completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejun
Korea, Republic of	Research Site	Kwangju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Sungman
Korea, Republic of	Research Site	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis		Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis	No
Secondary	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	No