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

Non-erosive Reflux Disease (NERD) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536080
• Other study ID #: D9612L00150
• Status: Completed
• Phase: N/A
• First received: February 13, 2012
• Last updated: February 15, 2012
• Start date: July 2008

Study information

• Verified date: February 2012
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 85 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Esophagitis
• Esophagitis, Peptic
• Functional Heartburn (FH)
• Gastroesophageal Reflux
• Heartburn
• Non-erosive Reflux Disease (NERD)
• Reflux Esophagitis (RE)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Bundang-gu, Seongnam	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The GIS score at baseline		Before 8 weeks PPI treatment(baseline)	No
Secondary	Change of the GIS score from baseline		After 8 weeks PPI treatment	No