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Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.

Primary Purpose

Esophageal Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rabeprazole 20mg bid
Rabeprazole 20mg qd
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Disease focused on measuring Gastroesophageal Reflux

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age is over 20 years old, under 80 years old, men or women
  • Patients who had experienced extra-esophageal symptoms of gastroesophageal reflux disease more than once a week within the last month prior to the start of the study

Exclusion Criteria:

  • Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks
  • Patients administered with anti-thrombotic drugs
  • Patients taking other investigational drugs or participating in other clinical studies in 4 weeks
  • Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding
  • Patients with Zollinger-Ellison syndrome
  • Patients with any kind of malignant tumor
  • Patients with surgery related to gastroesophageal
  • Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease
  • Patients with neuropsychiatric disorder, alcoholism, or drug abuse
  • Women either pregnant or breast feeding

Sites / Locations

  • Seoul National University Bungdang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-dose rabeprazole

Standard-dose rabeprazole

Arm Description

Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks

Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks

Outcomes

Primary Outcome Measures

Effective improvement of symptoms
A percentage of subjects showed effective improvement of extra-esophageal symptoms of gastroesophageal reflux disease by assessing the average sum of the questionnaire symptom scores. The definition of "effective improvement" is the subjects showed ≥50% reduction from the initial questionnaire score. The symptom questionnaire consists of a 5-graded Likert scale for each symptom to assess intensity of symptoms. [score 0: no symptoms, score 1: mild symptoms that is not easily felt, score 2: moderate symptoms but not affect daily life, score 3: severe symptoms that hinder daily life or sleep, score 4: very severe symptoms that cannot lead to normal daily life or sleep] In this trial, extra-esophageal symptoms consist of eight symptoms; non-cardiac chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching and dysphagia.

Secondary Outcome Measures

Full Information

First Posted
June 26, 2019
Last Updated
June 26, 2019
Sponsor
Seoul National University Hospital
Collaborators
IlDong Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04001400
Brief Title
Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
Official Title
Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2012 (Actual)
Primary Completion Date
May 21, 2014 (Actual)
Study Completion Date
May 21, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
IlDong Pharmaceutical Co Ltd

4. Oversight

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

5. Study Description

Brief Summary
This is a single-center, randomized, open-label clinical study to assess the treatment response of high-dose rabeprazole compared with standard-dose rabeprazole in patients with extra-esophageal manifestations of gastroesophageal reflux disease.
Detailed Description
Gastroesophageal reflux disease is a condition in which reflux of stomach contents into the esophagus. This disease can be classified in to two subtypes according to the symptoms; Typical symptoms such as heartburn and regurgitation, and atypical symptoms (extra-esophageal symptoms) such as chronic cough, asthma, non-cardiac chest pain, globus sensation, etc. Acid suppression with proton pump inhibitors is the mainstream of therapy for the extra-esophageal manifestation as well as the typical symptoms of gastroesophageal reflux disease. However, there is controversy about the efficacy of proton pump inhibitors on extra-esophageal reflux. Therefore, we aimed to assess the effect of proton pump inhibotor (rabeprazole) on the extra-esophageal manifestation of gastroesophageal reflux disease, through comparison of treatment response with high-dose and standard-dose rabeprazole.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Disease
Keywords
Gastroesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-dose rabeprazole
Arm Type
Experimental
Arm Description
Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
Arm Title
Standard-dose rabeprazole
Arm Type
Active Comparator
Arm Description
Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Rabeprazole 20mg bid
Other Intervention Name(s)
Rabiet
Intervention Description
Rabeprazole 20mg tablet b.i.d.
Intervention Type
Drug
Intervention Name(s)
Rabeprazole 20mg qd
Other Intervention Name(s)
Rabiet
Intervention Description
Rabeprazole 20mg tablet q.d.
Primary Outcome Measure Information:
Title
Effective improvement of symptoms
Description
A percentage of subjects showed effective improvement of extra-esophageal symptoms of gastroesophageal reflux disease by assessing the average sum of the questionnaire symptom scores. The definition of "effective improvement" is the subjects showed ≥50% reduction from the initial questionnaire score. The symptom questionnaire consists of a 5-graded Likert scale for each symptom to assess intensity of symptoms. [score 0: no symptoms, score 1: mild symptoms that is not easily felt, score 2: moderate symptoms but not affect daily life, score 3: severe symptoms that hinder daily life or sleep, score 4: very severe symptoms that cannot lead to normal daily life or sleep] In this trial, extra-esophageal symptoms consist of eight symptoms; non-cardiac chest pain, cough, globus, wheezing, laryngopharyngitis, hoarseness, belching and dysphagia.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age is over 20 years old, under 80 years old, men or women Patients who had experienced extra-esophageal symptoms of gastroesophageal reflux disease more than once a week within the last month prior to the start of the study Exclusion Criteria: Patients administered with prokinetics, H2 receptor antagonists, proton pump inhibitors, anticholinergic drugs or non-steroid anti-inflammatory drugs prior to study in 4 weeks Patients administered with anti-thrombotic drugs Patients taking other investigational drugs or participating in other clinical studies in 4 weeks Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding Patients with Zollinger-Ellison syndrome Patients with any kind of malignant tumor Patients with surgery related to gastroesophageal Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease Patients with neuropsychiatric disorder, alcoholism, or drug abuse Women either pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong Ho Lee, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bungdang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32811427
Citation
Cho JH, Shin CM, Yoon H, Park YS, Kim N, Lee DH. Efficacy of a high-dose proton pump inhibitor in patients with gastroesophageal reflux disease: a single center, randomized, open-label trial. BMC Gastroenterol. 2020 Aug 18;20(1):275. doi: 10.1186/s12876-020-01410-z.
Results Reference
derived

Learn more about this trial

Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.

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