Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

NCT ID: NCT01797939

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 197 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2012-12-31

Brief Summary

Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still remain controversial. Therefore, the aims of this study were to investigate the efficacy of PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).

Conditions

Erosive Reflux Disease; Non-erosive Reflux Disease; Functional Heartburn

Study Design

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

Study Groups

Erosive reflux disease (ERD)

No interventions assigned to this group

Non-erovise 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 participants with GERD symptoms were treated a PPI therapy.
• The participants completed a questionnaire. The questionnaire consisted of demographic data, GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).

Exclusion Criteria

• Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, peptic ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) were excluded.
• Patients who took the PPI therapy less than 4 weeks were excluded.

• 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

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

B-1302-192-107

Identifier Type: -

Identifier Source: org_study_id