Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

NCT01797939 | Completed

• 1 other identifier: B-1302-192-107
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Predictors of the response to PPI treatment in patients with symptomatic GERD

  After 8 weeks of initial PPI administration

Study Arms (3)

Erosive reflux disease (ERD)

Non-erovise 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 erosive reflux disease(ERD), non-erosive reflux disease (NERD) and even functional heartburn (FH).

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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 21, 2013
• First Posted: February 25, 2013
• Study Start: July 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

KR (1)