Clinical trial: Verification Study on Lafutidine in Mild Reflux Oesophagitis - Double Blind Controlled Study With Famotidine - (NCT00229424)

Eligibility criteria:
Inclusion Criteria:

          -  Age 20 and over (at the time of consent given)

          -  Gender and inpatient or outpatient: Irrelevant

          -  Patients diagnosed with Grade A or Grade B mild reflux oesophagitis (according to the
             Los Angels classification) through endoscopic test

          -  Patients who complained about "heartburn symptom" within one week prior to the
             enrollment

        Exclusion Criteria:

          -  Patients whose "heartburn symptom" has been disappeared (not been observed at all)
             during the observation period (Check before official enrollment)

          -  Patients in ill compliance with dosing the investigational product for the observation
             period (Not more than 75%, check from the patient dairy before official enrollment)

          -  Patients the investigator/sub-investigator assessed difficult to complete the patient
             diary during the treatment period because the patient diary for the observation period
             has too many deficiencies. (Check before official enrollment)

          -  Patients with complication of gastric/duodenal ulcer (scarring acceptable)

          -  Patients with complication of Barrett lining over the site exceeding 3 cm of
             esophageal distal portion

          -  Patients who have received the normal dose of H2 receptor antagonist or proton pump
             inhibitor (PPI) for 8 weeks in vain

          -  Patients whose Helicobacter pylori was successfully eradicated within 24 weeks

          -  Patients with medical history of upper gastrointestinal tract excision

          -  Patients with complication of angina pectoris

          -  Patients who have received treatment of any other investigational product within 12
             weeks

          -  Patients who showed any of the following values at the laboratory tests before
             official enrollment: Hemoglobin: < 9.5 g/dL, WBC: < 3,000/mm^3, Thrombocytes: <
             75,000/mm^3, AST and ALT : ≥ 100 IU/L, Creatinine: ≥ 1.5 mg/dL These should be
             assessed using the current test values from the blood drawn within 4 weeks prior to
             official enrollment.

          -  Patients with complication of serious cardiac disorder (Grade 3 or above under PAB/SD
             Notification No. 80) For example, patients with triplet or more ventricular premature
             contractions (multi-sources) or using a pacemaker

          -  Patients with medical history of serious hypersensitivity to drugs (Grade 3 or above
             under PAB/SD Notification No. 80)

          -  Patients who receive treatment of cancer

          -  Women of confirmed or potential pregnancy, those who wish to become pregnant, and
             breast feeding women

          -  Patients having any other condition that, in the opinion of the
             investigator/sub-investigator disqualifies them for the trial
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