Clinical trial: The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD (NCT01860482)

Eligibility criteria:
Inclusion Criteria:

          1. Male or Female aged ≥ 20 years

          2. Reflux esophagitis with erosion or ulceration confirmed by endoscopic exam.

          3. Refractory reflux esophagitis to PPIs standard treatment as follows

               1. Ongoing heartburn symptom with or without these GERD-related symptoms :
                  Regurgitation, Non-cardiac chest pain, Epigastric pain, Belching, Bloating,
                  Satiety, Sore throat, Cough, Laryngitis, Hoarseness, Nausea, Vomiting, Dysphagia,
                  Odynophagia, Weight loss

               2. Ongoing heartburn symptom with or without erosion ≥ grade A according to LA
                  Classification

          4. Ongoing heartburn symptoms ≥ 2 days during 1week right before administering first dose
             of IP

          5. Decided to participate and signed on an informed consent form willingly

        Exclusion Criteria:

          1. Existence of upper gastrointestinal bleeding or active gastroduodenal ulcer at
             screening

          2. History of operation in esophagus, stomach or duodenum

          3. The following medical history

               1. Primary esophageal motility disease, Achalasia, Scleroderma, Esophageal/pyloric
                  stricture, Primary esophageal spasm

               2. Barrett's esophagus ≥ 3 cm

               3. Zollinger-Ellison syndrome

               4. Infectious or inflammatory bowel disease, Severe malabsorption

          4. Severe chronic heart failure, cardiovascular disease, renal failure, COPD, asthma,
             liver cirrhosis

          5. History of cancer within 5 years, except completely recovered skin cancer

          6. ALT or AST ≥ Upper limit of normal range X 3

          7. Need antibiotics due to severe infection

          8. Severe medical disease that needs these prohibited medication

               -  Anticoagulant(Heparin, Warfarin, etc.), High dose of aspirin(>325mg/d),
                  Digitalis(Digoxin, etc.), Diuretics, Atazanavir, NSAIDs or Steroids

          9. Use PPIs or H2RA medicine within 1 week before administering first dose of IP, or need
             other PPIs or H2RA medicine during trial period

         10. Allergy or hypersensitivity to IP or similar chemical structure(Benzimidazol
             derivatives, etc.)

         11. Pregnant or breast-feeding women

         12. Conversation impairment because of alcohol, drug addiction or mental illness, etc.

         13. Administration of other IP within 28 days

         14. Inability to record heartburn diary card

         15. In investigator's judgement
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.


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? Contradiction