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

NCT03436914 | Completed

• 1 other identifier: 4-2017-1143
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-erosive Gatroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)

  Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients

  8 weeks

Secondary Outcomes (1)

• The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota

  8 weeks

Study Arms (1)

PPI

EXPERIMENTAL

Esomezol®

Drug: PPI

Interventions

PPI DRUG

After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed.

Also known as: Esomezol®

PPI

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university College of Medicine

Seoul, 03722, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.

Study Record Dates

• First Submitted: February 12, 2018
• First Posted: February 19, 2018
• Study Start: September 1, 2018
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)