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

Esophageal Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04001400
• Other study ID #: SNUBH-DHLIDRA
• Status: Completed
• Phase: Phase 3
• Start date: October 10, 2012
• Est. completion date: May 21, 2014

Study information

• Verified date: June 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: May 21, 2014
• Est. primary completion date: May 21, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Disease
• Esophageal Diseases
• Gastroesophageal Reflux

Intervention

Drug:
• Rabeprazole 20mg bid
Rabeprazole 20mg tablet b.i.d.
• Rabeprazole 20mg qd
Rabeprazole 20mg tablet q.d.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bungdang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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