NCT04001400

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

Treatment Response of High-dose and Standard-dose Rabeprazole for Gastroesophageal Reflux Disease With Extra-esophageal Manifestations: a Single-center, Randomized, Open-label Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Disease

Interventions

Type	Name	Description
DRUG	Rabeprazole 20mg bid	Rabeprazole 20mg tablet b.i.d.
DRUG	Rabeprazole 20mg qd	Rabeprazole 20mg tablet q.d.

Timeline

• Start date: 2012-10-10
• Primary completion: 2014-05-21
• Completion: 2014-05-21
• First posted: 2019-06-28
• Last updated: 2019-06-28

Locations

1 site across 1 country: South Korea