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

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ClinicalTrials.gov Identifier: NCT00901004
Recruitment Status : Completed
First Posted : May 13, 2009
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
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.

Condition or disease
Gastroesophageal Reflux Disease

Study Type : Observational
Actual Enrollment : 1550 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : April 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Group/Cohort
1
Reflux esophageal minimal change in the endoscopic finding



Primary Outcome Measures :
  1. To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis [ Time Frame: Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis ]

Secondary Outcome Measures :
  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. [ Time Frame: at baseline -->this is a cross-sectional study ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had shown the reflux esophageal minimal change in the endoscopic finding
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00901004


Locations
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, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Joonwoo Bahn Astrazenca Korea, Medical Department

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00901004     History of Changes
Other Study ID Numbers: NIS-GKR-DUM-2009/1
First Posted: May 13, 2009    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
Minimal Change
GERD
GERDQ

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases