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Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

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Seoul National University

Status

Completed

Conditions

Erosive Reflux Disease
Non-erosive Reflux Disease
Functional Heartburn

Study type

Observational

Funder types

Other

Identifiers

NCT01797939
B-1302-192-107

Details and patient eligibility

About

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).

Enrollment

197 patients

Sex

All

Ages

16 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

197 participants in 3 patient groups

Erosive reflux disease (ERD)
Non-erovise reflux disease (NERD)
Functional heartburn (FH)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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