Efficacy of DA-5204 on Gastroesophageal Reflux Disease

• Status: Completed
• Trial end date: 2018-12-11
• Target enrollment: 0
• Participant gender: All

Summary

This is a single-center, randomized, double-blind, placebo-controlled clinical Study to evaluate the efficacy of DA-5204 and proton pump inhibitor combination therapy compared with proton pump inhibitor alone therapy in patients with gastroesophageal reflux Disease.

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

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: Dong-A ST Co., Ltd.
• Treatments: Pantoprazole

Criteria

Inclusion Criteria:

• Age is over 20 years old, under 75 years old, men or women

• Patients diagnosed with erosive esophagitis by gastroscopy

• Signed the informed consent forms

Exclusion Criteria:

• Patients who is impossible to receive gastroscopy

• Patients with esophageal stricture, esophageal varix, Barrett's esophagus, peptic ulcer or gastrointestinal bleeding

• 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 with surgery related to gastroesophageal

• Patients with Zollinger-Ellison syndrome

• Patients with any kind of malignant tumor

• Patients administered with anti-thrombotic drugs

• Patients with significant cardiovascular, pulmonary, heptic, renal, hemopoietic or endocrine system primary disease

• Patients with neuropsychiatric disorder, alcoholism, or drug abuse

• Patients taking other investigational drugs or participating in other clinical studies in 4 weeks.

• Women either pregnant or breast feeding