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

NCT01536080 | Completed

• 1 other identifier: D9612L00150
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• The GIS score at baseline

  Before 8 weeks PPI treatment(baseline)

Secondary Outcomes (1)

• Change of the GIS score from baseline

  After 8 weeks PPI treatment

Study Arms (3)

Reflux esophagitis (RE)

Non-erosive reflux disease (NERD)

Functional heartburn (FH)

Eligibility Criteria

• Age: 16 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Bundang-gu, Seongnam, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Esophagitis, Peptic; Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D.

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 20, 2012
• Study Start: July 1, 2008
• Last Updated: February 20, 2012

Record last verified: 2012-02

Locations

KR (1)