Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease; Heartburn
MeSH terms: Gastroesophageal Reflux; Heartburn
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Sodium alginate; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): oral suspension, 50 mg/ml, 20 ml three times daily, 4 weeks; 20 mg capsule, 1 capsule once daily, 4 weeks
Other intervention name(s): Alginos; Omelon
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alginate; Gastroesophageal reflux disease