Clinical trial NCT04001400: Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Esophageal Disease
Keywords: Gastroesophageal Reflux
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: IlDong Pharmaceutical Co Ltd
First posted: 2019-06-28
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effective improvement of symptoms
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bungdang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Dong Ho Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.