Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

Non-erosive Reflux Disease Clinical Trial

Official title:

Predictive Factors of Response to Proton Pump Inhibitor Treatment in Patients With Gastroesophageal Reflux Disease Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797939
• Other study ID #: B-1302-192-107
• Status: Completed
• Phase: N/A
• First received: February 21, 2013
• Last updated: February 22, 2013
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: February 2013
• 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• 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 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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Erosive Reflux Disease
• Functional Heartburn
• Gastroesophageal Reflux
• Heartburn
• Non-erosive Reflux Disease

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	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	Efficacy of PPI therapy in these erosive reflux disease (ERD), non-erosive reflux disease (NERD), and functional heartburn (FH) groups	Responses of dyspeptic symptoms were classified into 4 sections, as follows: complete response (more than 80% of symptom resolution), satisfactory response (symptoms remained less than 50%), partial response (symptoms remained for more than 50%), and refractory response (unresponsive to the eradication therapy). Then, the symptom responses were classified into 2 groups: responder with complete or satisfactory subgroup, and non-responder with partial or refractory responder subgroup.	After 8 weeks of initial PPI administration	No
Secondary	Predictors of the response to PPI treatment in patients with symptomatic GERD	The participants were evaluated the predictors of PPI response 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).	After 8 weeks of initial PPI administration	No