Efficacy of DA-5204 on Gastroesophageal Reflux Disease (NCT03998969) | Clinical Trial Compass
CompletedPhase 3
Efficacy of DA-5204 on Gastroesophageal Reflux Disease
South Korea70 participantsStarted 2016-06-01
Plain-language 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.
Who can participate
Age range20 Years – 75 Years
SexALL
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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