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

Non-erosive Gatroesophageal Reflux Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436914
• Other study ID #: 4-2017-1143
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 18, 2019

Study information

• Verified date: December 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patient over 19 years old

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

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.

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Non-erosive Gatroesophageal Reflux Disease

Intervention

Drug:
• PPI
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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei university College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota	The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI	8 weeks