Treatment Response of High-dose and Standard-dose Rabeprazole for Extra-esophageal Reflux.
NCT ID: NCT04001400
Last Updated: 2019-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
73 participants
INTERVENTIONAL
2012-10-10
2014-05-21
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-dose rabeprazole
Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
Rabeprazole 20mg bid
Rabeprazole 20mg tablet b.i.d.
Standard-dose rabeprazole
Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks
Rabeprazole 20mg qd
Rabeprazole 20mg tablet q.d.
Interventions
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Rabeprazole 20mg bid
Rabeprazole 20mg tablet b.i.d.
Rabeprazole 20mg qd
Rabeprazole 20mg tablet q.d.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
80 Years
ALL
No
Sponsors
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IlDong Pharmaceutical Co Ltd
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Dong Ho Lee
Director, Clinical Research
Principal Investigators
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Dong Ho Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bungdang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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References
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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.
Other Identifiers
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SNUBH-DHLIDRA
Identifier Type: -
Identifier Source: org_study_id