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OpenTrials
Completed

NCT Number: NCT01536080

Analysis of GERD Symptoms Using Gastroesophageal Reflux Impact Score Questionnaire for Quality of Life

Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (RE), non-erosive reflux disease (NERD) and even functional heartburn (FH). In addition, the GERD symptoms are consisted of esophageal symptoms and extraesophageal symptoms. Thus it is necessary to use effective tool for the measurement of GERD symptoms and response of proton pump inhibitor in short time. Several questionnaires have been made for the assessment of GERD symptoms in recent years However, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. The GERD impact scale (GIS) questionnaire has been developed to compensate for this. It is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. However, there was no report regarding comparison of the characteristics and response to PPI in RE, NERD and FH groups using GIS questionnaire so far.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult Subjects (From 16 to 85 years old)
  • The subjects with GERD symptom who received 8 week PPI therapy

Exclusion criteria

  • Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus)
  • Patients who took H2 blocker or a PPI to relieve these symptoms within 4 weeks

Treatment and study plan

Primary outcomes

  1. The GIS score at baseline

    Time frame: Before 8 weeks PPI treatment(baseline)

Secondary outcomes

  1. Change of the GIS score from baseline

    Time frame: After 8 weeks PPI treatment

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

Comparison of Risk Factors, GERD Symptoms and PPI Responses in the Reflux Esophagitis, Non-erosive Reflux Disease and Functional Heartburn Using GERD Impact Scale Questionnaire

Important dates

Study start
2008
First posted
Feb 20, 2012
Registry last updated
Feb 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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