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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01536080
First received: February 13, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • The GIS score at baseline [ Time Frame: Before 8 weeks PPI treatment(baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of the GIS score from baseline [ Time Frame: After 8 weeks PPI treatment ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: July 2008
Groups/Cohorts
Reflux esophagitis (RE)
Non-erosive reflux disease (NERD)
Functional heartburn (FH)

  Eligibility

Ages Eligible for Study:   16 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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).

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01536080

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Bundang-gu, Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Nayoung Kim, Professor, M.D., Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01536080     History of Changes
Other Study ID Numbers: D9612L00150
Study First Received: February 13, 2012
Last Updated: February 15, 2012
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014