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

NCT04001400 | Completed Phase 3

• 1 other identifier: SNUBH-DHLIDRA
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Disease

Keywords

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

High-dose rabeprazole

EXPERIMENTAL

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

Drug: Rabeprazole 20mg bid

Standard-dose rabeprazole

ACTIVE COMPARATOR

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

Drug: Rabeprazole 20mg qd

Interventions

Rabeprazole 20mg bid DRUG

Rabeprazole 20mg tablet b.i.d.

Also known as: Rabiet

High-dose rabeprazole

Rabeprazole 20mg qd DRUG

Rabeprazole 20mg tablet q.d.

Also known as: Rabiet

Standard-dose rabeprazole

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• IlDong Pharmaceutical Co Ltd: collaborator

Study Sites (1)

Seoul National University Bungdang Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 32811427 DERIVED

MeSH Terms

Conditions

Esophageal Diseases; Gastroesophageal Reflux

Interventions

Rabeprazole; BID protein, human

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Esophageal Motility Disorders; Deglutition Disorders

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Dong Ho Lee, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Research

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: June 28, 2019
• Study Start: October 10, 2012
• Primary Completion: May 21, 2014
• Study Completion: May 21, 2014
• Last Updated: June 28, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)