Back to resultsTreatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Primary Purpose
Non-erosive Gatroesophageal Reflux Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
PPI
Sponsored by
About this trial
This is an interventional treatment trial for Non-erosive Gatroesophageal Reflux Disease
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.
Sites / Locations
- Yonsei university College of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PPI
Arm Description
Esomezol®
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03436914
Brief Title
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Official Title
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Gatroesophageal Reflux Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
There is only one arm in this study. Patients diagnosed as NERD will take PPI (Esomezol) for 8 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PPI
Arm Type
Experimental
Arm Description
Esomezol®
Intervention Type
Drug
Intervention Name(s)
PPI
Other Intervention Name(s)
Esomezol®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol)
Description
Scoring the PAGI-SYM to analyze the satisfaction of symptoms (heartburn and regurgitation) after 8 weeks of PPI administration to NERD patients
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota
Description
The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Yonsei university College of Medicine
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
We'll reach out to this number within 24 hrs