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 range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Endoscopically effective improvement

Timeframe: 4 weeks

Endoscopically complete improvement

Timeframe: 4 weeks

Trial details

NCT IDNCT03998969

SponsorSeoul National University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-12-11

View on ClinicalTrials.gov More Esophageal Disease trials

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.