Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chang Gung Memorial Hospital
• Treatments: Alginic acid; Omeprazole

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