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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03436914
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : February 20, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Non-erosive Gatroesophageal Reflux Disease Drug: PPI

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Treatment Response of Maintenance Dose of Proton Pump Inhibitor in Patients With Nonerosive Gatroesophageal Reflux Disease
Anticipated Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : January 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arm Intervention/treatment
Experimental: PPI
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.
Other Name: Esomezol®

Primary Outcome Measures :
  1. Proportion of PAGI-SYM score (0-2) patients after 8 weeks of PPI(Esomezol) [ Time Frame: 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 :
  1. The analysis of factors affecting the PAGI-SYM inculding immunolgic array and esophagus mucosal microbiota [ Time Frame: 8 weeks ]
    The analysis of complete symptom (regurgitation, heartburn) remission (PAGI-SYM score 0) after 8weeks of PPI

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03436914

Korea, Republic of
Yonsei university College of Medicine Not yet recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang Kil Lee, MD    82-2-2228-1996   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University Identifier: NCT03436914     History of Changes
Other Study ID Numbers: 4-2017-1143
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action