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

NCT ID: NCT01536080

Last Updated: 2012-02-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 207 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Reflux esophagitis (RE)

No interventions assigned to this group

Non-erosive reflux disease (NERD)

No interventions assigned to this group

Functional heartburn (FH)

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nayoung Kim

Professor, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

D9612L00150

Identifier Type: -

Identifier Source: org_study_id