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

Seoul National University

Status and phase

Completed

Phase 3

Conditions

Esophageal Disease

Treatments

Drug: Rabeprazole 20mg qd

Drug: Rabeprazole 20mg bid

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04001400

SNUBH-DHLIDRA

Details and patient eligibility

About

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.

Full 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.

Enrollment

73 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No 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