Clinical trial: Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease (NCT01338077)

Eligibility criteria:
Inclusion Criteria:

          -  Patients with age of 20-75 years old (inclusive) in Taiwan of both genders

          -  Out-patients who had been diagnosed as non-erosive gastroesophageal reflux disease
             (NERD)

          -  Patients with heartburn or regurgitation (either one) as main symptom at least 2 days
             a week and had been present for > or = 1 month before screening

          -  Patients with heartburn or regurgitation (either one) during the 7 days screening
             period, either with frequency for > or = 4 days of mild symptom, or for > or = 2 days
             of moderate to severe symptom

          -  Patients have signed the informed consent form

        Exclusion Criteria:

          -  Patients with erosive gastroesophageal reflux disease (GERD), Barrett's esophagus or
             esophageal stricture

          -  Patients with active or healing gastroduodenal ulcer (except scars)

          -  Patients with history of gastric, duodenal or esophageal surgery

          -  Patients with malignant disease of any kind

          -  Patients with intrahepatic stone, gallstone, gallbladder sludge, hepatic or pancreatic
             carcinoma as evidenced by abdominal ultrasonography

          -  Patients with ischemic heart disease as evidenced by electrocardiogram

          -  Female patients who are pregnant or nursing mother

          -  Patients with a history of allergy to any of the study drugs or their related
             compounds

          -  Patients with a history of alcohol or drug abuse

          -  Patients with clinically significant liver disease (aspartate aminotransferase (AST),
             alanine aminotransferase (ALT)>2 upper limits of normal)

          -  Patients with clinically significant renal disease (serum creatinine >1.5 mg/dl)

          -  Patients taken a proton pump inhibitor (PPI) within 14 days before screening, or a
             H2-blocker, prokinetic agent or antacid within 7 days before screening

          -  Patients participated any investigational drug trial within 4 weeks before screening

          -  Patients with any other conditions or diseases that investigator considers it is not
             appropriate to enter the study
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 75 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? Contradiction