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

NCT ID: NCT03436914

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-10-18

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.

Conditions

Non-erosive Gatroesophageal Reflux Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PPI

Esomezol®

Group Type: EXPERIMENTAL

PPI

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Esomezol®

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yonsei university College of Medicine

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2017-1143

Identifier Type: -

Identifier Source: org_study_id