A Phase 3 interventional study of Rabeprazole 20mg bid and Rabeprazole 20mg qd in Esophageal Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-06-28.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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.
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.
1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.
This study's enrollment of 73 is close to the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Rabeprazole 20mg twice daily by mouth before breakfast and dinner for 8 weeks
Drug: Rabeprazole 20mg bid
Rabeprazole 20mg once daily by mouth before breakfast for 8 weeks
Drug: Rabeprazole 20mg qd
Rabeprazole 20mg tablet b.i.d.
Also known as: Rabiet
Rabeprazole 20mg tablet q.d.
Also known as: Rabiet
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.
Time frame: 8 weeks
Plan to share: No
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital