Clinical trial NCT00901004: The Clinical Significance of Minimal Change in Reflux Esophagitis Based on the Gastroesophageal Reflux Disease Questionnaire
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux Disease
Keywords: Minimal Change
GERD
GERDQ
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-05-13
Enrollment: 1550
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had shown the reflux esophageal minimal change in the endoscopic finding

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.


Eligibility criteria: 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

Primary outcomes:
measure: To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis
timeFrame: Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis
Secondary outcomes:
measure: 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.
timeFrame: at baseline -->this is a cross-sectional study
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejun
country: Korea, Republic of
facility: Research Site
city: Kwangju
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Sungman
country: Korea, Republic of
facility: Research Site
city: Suwon
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Astrazenca Korea, Medical Department
name: Joonwoo Bahn
role: STUDY_DIRECTOR
References: