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

Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial.

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Disease
• Intervention / Treatment: Drug: Rabeprazole 20mg bid; Drug: Rabeprazole 20mg qd

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.

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bungdang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-dose rabeprazole; Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks	Drug: Rabeprazole 20mg bid; Rabeprazole 20mg tablet b.i.d.; Other Names: Rabiet
ACTIVE_COMPARATOR: Standard-dose rabeprazole; Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks	Drug: Rabeprazole 20mg qd; Rabeprazole 20mg tablet q.d.; Other Names: Rabiet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: IlDong Pharmaceutical Co Ltd

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2012
• Primary Completion (ACTUAL): May 21, 2014
• Study Completion (ACTUAL): May 21, 2014

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (ACTUAL): June 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 26, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Gastroesophageal Reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Gastroesophageal Reflux; Esophageal Diseases; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: SNUBH-DHLIDRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No