Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease

Not Applicable

Completed

• Conditions: Non-erosive Gatroesophageal Reflux Disease
• Interventions: Drug: PPI

• Registration Number: NCT03436914
• Lead Sponsor: Yonsei University

Brief Summary

For ERD(erosive reflux disease), which pathogenesis is mainly the acid reflux mechanism, primary treatment is therefore PPI. However, NERD(non-erosive reflux disease) is much more complex than ERD and there are more factors causing the typical symptoms. As a result, there is no consensus for the treatment of NERD besides using PPI similar to GERD(gastroesophageal reflux diseas). This study intent to evaluate the effect of PPI(Esomezol) on NERD patients and analyze the improvement of symptoms and the factors related to the result.

Detailed Description

(1) Among GERD patients, EGD(esophagogastroduodenoscopy) must be done before 6 months and must prove there is no erosive lesion. (2) During EGD, esophagus mucosa histology will be taken for evaluation. (3) For NERD patients, Esomezol is given once a day (before breakfast meal), for whole 8 weeks. (4) PAGI-SYM and HAD-K is evaluated and score just before the administration of PPI, 4weeks after and 8weeks after the study initiation.

Study Timeline

• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-12
• Study First Posted: 2018-02-19
• Study Start: 2018-09-01
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-27
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

• Patient over 19 years old
• Patient with typical GERD symptom (heartburn or acid reflux more than once a week)

Read More

Exclusion Criteria

• Patient who received EGD since the past 6 months, and diagnosed as GERD endoscopically
• Patient with active gastric/duodenal ulcer
• Patient who received esophagus, stomach or duodenum surgery
• Patient with hypersensitivity to esomezol®
• Patient with no achieved agreement on the study from the guardian or patient himself.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PPI	PPI	Esomezol®

Primary Outcome Measures

Name	Time	Method
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)	8 weeks	Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients

Secondary Outcome Measures

Name	Time	Method
The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota	8 weeks	The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI

Trial Locations

Locations (1)

Yonsei university College of Medicine; 🇰🇷 Seoul, Korea, Republic of