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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00901004
First received: April 28, 2009
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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
Gastroesophageal Reflux Disease

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To investigate significant minimal change endoscopic finding of reflux esophagitis diagnosis [ Time Frame: Significant minimal change endoscopic finding for gastroesophageal reflux disease diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1550
Study Start Date: April 2009
Study Completion Date: September 2009
Groups/Cohorts
1
Reflux esophageal minimal change in the endoscopic finding

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00901004     History of Changes
Other Study ID Numbers: NIS-GKR-DUM-2009/1
Study First Received: April 28, 2009
Last Updated: December 6, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Minimal Change
GERD
GERDQ

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

ClinicalTrials.gov processed this record on November 25, 2014