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Completed

NCT Number: NCT04001400

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

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.

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Key information

Conditions

Esophageal Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bungdang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rabeprazole 20mg bid

Drug

Rabeprazole 20mg tablet b.i.d.

Other names: Rabiet

Rabeprazole 20mg qd

Drug

Rabeprazole 20mg tablet q.d.

Other names: Rabiet

Primary outcomes

  1. Effective improvement of symptoms

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • IlDong Pharmaceutical Co Ltd

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 28, 2019
Registry last updated
Jun 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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