Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and
 regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD
 show an overall poorer response to PPI treatment than patients with erosive reflux disease.
 Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal
 reflux symptoms. This multi-center, double blind, randomized trial aims to compare the
 efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times
 daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD
 patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate
 relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms
 as assessed by reflux disease questionnaire before and after treatment, and patients overall
 satisfaction at the end of study. Safety assessments include incidence of adverse events and
 change of the laboratory test results. The study hypothesis is that treatment with sodium
 alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of
 the NERD patients.
This multi-center, double blind, randomized trial aims to compared the efficacy and safety
 profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of
 omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of non-erosive reflux
 disease (NERD) patients in Taiwan. Patients will be included into study if they are diagnosed
 as NERD; with heartburn or regurgitation (either one) as main symptom at least 2 days a week
 and had been present for ≧1 month before screening; with heartburn or regurgitation (either
 one) during the 7 days screening period, either with frequency for ≧4 days of mild symptom,
 or ≧ 2 days of moderate to severe symptom; and have signed the informed consent. Patients
 will be excluded if they are diagnosed as erosive gastroesophageal reflux disease (GERD),
 Barrett's esophagus or esophageal stricture; with active or healing gastroduodenal ulcer
 (except scars); with history of gastric, duodenal or esophageal surgery; with intrahepatic
 stone, gallstone, gallbladder sludge, hepatic or pancreatic carcinoma as evidenced by
 abdominal ultrasonography, with ischemic heart disease as evidenced by electrocardiogram;
 taking a proton pump inhibitor (PPI) within 14 days before screening, or a H2-blocker,
 prokinetic agent or antacid within 7 days before screening; or with clinically significant
 liver or kidney disease. The primary efficacy endpoint is percentage of patients achieving
 adequate heartburn (defined as a burning feeling or pain behind the breast bone) or
 regurgitation (defined as an acid taste in the mouth or unpleasant movement of material
 upwards from the stomach) relief at day 28 as assessed by patient diary. The secondary
 efficacy endpoints are percentage of patients achieving adequate heartburn or regurgitation
 relief at day 14; change from baseline of the reflux disease questionnaire total score at day
 14 & 28; patients' overall satisfaction at the end of study; and number of antacid used
 during the 4-week treatment period. The safety endpoints are incidence of adverse events, and
 changes in laboratory test results (hematology, biochemistry, and urinalysis). The study
 hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving
 heartburn or regurgitation symptoms of the NERD patients.
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