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

• Status: Completed
• Trial end date: 2014-05-21
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: IlDong Pharmaceutical Co Ltd
• Treatments: Rabeprazole

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