Esophageal Disease Clinical Trial
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.
Verified date | June 2019 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 73 |
Est. completion date | May 21, 2014 |
Est. primary completion date | May 21, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bungdang Hospital | Seongnam-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | IlDong Pharmaceutical Co Ltd |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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