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

Completed

• Conditions: Reflux Esophagitis (RE); Functional Heartburn (FH); Non-erosive Reflux Disease (NERD)

• Registration Number: NCT01536080
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-07
• Status Verified: 2012-02
• Study First Submitted: 2012-02-13
• Study First Submitted QC: 2012-02-15
• Last Update Submitted: 2012-02-15
• Study First Posted: 2012-02-20
• Last Update Posted: 2012-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The GIS score at baseline	Before 8 weeks PPI treatment(baseline)

Secondary Outcome Measures

Name	Time	Method
Change of the GIS score from baseline	After 8 weeks PPI treatment

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of