Clinical trial: Clinical Trial to Assess the Efficacy and Safety of YYD601 in NERD Patients (NCT03967886)

Eligibility criteria:
Inclusion Criteria:

          -  A man or woman over 20 years old less than 70 years old.

          -  A man or woman who has below all characters and diagnosis as NERD.

               1. A man or woman who has experienced symptom(hearburn or/and acid regurgitation)
                  over 3month at least.

               2. A man or woman who has experienced symptom(heartburn or/and acid regurgitation)
                  within 7days before Visit1, meet below 1) or 2) criteria.

                  ** Symptom (heartburn and acid regurgitation) is confirmed by RDQ

                    -  Experienced above 2 days in a week, heartburn of acid regurgitation above
                       the weakness.

                    -  Experienced above 1 day in a week, heartburn of acid regurgitation above the
                       middle.

               3. A man or woman who has been made diagnosis as LA grade0(Zero) measured through
                  the dendoscopy which is corried out within 14 days, there is no observed muscosal
                  break.

          -  A man or woman who has a full understanding of this clinical trial through the
             detailed explanation, agree in writing to participate in this trial.

        Exclusion Criteria:

          -  Who has hyper sensitivity reaction about other drugs, ingredients, components of
             investigator product or compound of benzimidazole.

          -  Who has ERD.

          -  Who get a diagnosis as a IBS within the last 3 months.

          -  Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA)
             Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (*
             refer to the Concomitant medication in text.)

          -  Who havbe taken gastric acid secretion inhibitors including PPIs within 2 weeks before
             the endoscopy.

          -  Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis,
             esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture,
             primary esophageal motility disorder and gastrointestinal bleeding). Or who has a
             history of radio therapeutics, freeze treatment about the esophagus.

          -  Who has the gastric or duodenal ulcer, Zollinger-Ellison and other acid hypersecretory
             condition been experienced.

          -  Who has hyper-sensitivity, reaction about PPIs (ex. Lansoprazole, omeprazole,
             rabeprazole, pantoprazole or esomeprazole).

          -  Who has gotten a diagnosis as a cancer within 5 years before participated in this
             clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 70 Years

Patient description (medical language): A 48-year-old man comes to the office complaining of heartburn and acid reflux.  He has taken over-the-counter antacids but sees no relief.  Other medical history is unremarkable.  The patient does not use tobacco, alcohol, or illicit drugs.  Vital signs are within normal limits.  BMI is 31 kg/m2.  Physical examination is  positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart.  A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus.

Patient description (patient's own words): I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm!

Does the patient match the trial criteria? 0